Danvers, MA, United States
Abiomed, Inc. recalls
31 recalls recorded since 2018, most recently on 12 August 2026. 27 are listed as ongoing. Status and classification are as published by the FDA.
Recalls31
Ongoing (FDA)27
Terminated or completed4
Class I (FDA)21
Ongoing Class I Medical devices
- Recall started
- 12 August 2026
- Reason
- The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
- Distribution
- Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ir
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3148-2026, Z-3149-2026, Z-3150-2026
- Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code:
- Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller, Packaged, EU; Produc
- Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-00
Ongoing Class I Medical devices
- Recall started
- 11 June 2026
- Reason
- A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- Distribution
- Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), France (FR), Germany (DE), Greece (GR), Hong Kong (HK), Ireland (IE), Israel (IL), Italy (IT), Japan (
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2682-2026, Z-2685-2026, Z-2683-2026, Z-2692-2026, Z-2689-2026, Z-2686-2026, Z-2688-2026, Z-2681-2026, Z-2691-2026, Z-2687-2026, Z-2693-2026, Z-2690-2026 and 1 more
- ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
- ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories
- ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories
- ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
- ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
- ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories
- ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
- ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
- and 5 more product lines
Ongoing Class I Medical devices
- Recall started
- 22 May 2026
- Reason
- Potential for thrombus formation during prolonged use of the introducer.
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2601-2026, Z-2600-2026, Z-2599-2026, Z-2602-2026
- Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
- Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
- Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
- Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Ongoing Class I Medical devices
- Recall started
- 18 May 2026
- Reason
- Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
- Distribution
- US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2457-2026
- Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Ongoing Class I Medical devices
- Recall started
- 14 May 2026
- Reason
- Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2360-2026
- Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impe
Ongoing Class I Medical devices
- Recall started
- 20 April 2026
- Reason
- A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, LA, MA, MI, MO, MS, ND, NY, OH, PA, TX, WY and the countries of Brazil, Canada, Colombia, Hong Kong, Italy, Kuwait, Saudi Arabia, UAE, United Kingdom;
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2211-2026
- Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Ongoing Class I Medical devices
- Recall started
- 18 February 2026
- Reason
- Increased risk of purge leaks with Generation 1 purge cassettes.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1589-2026
- Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2.
Ongoing Class I Medical devices
- Recall started
- 16 February 2026
- Reason
- Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
- Distribution
- International distribution in the country of Australia, Canada, France, Germany, Kuwait.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1591-2026
- Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0
Ongoing Class I Medical devices
- Recall started
- 27 January 2026
- Reason
- Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Italy, Poland, Serbia, Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1470-2026, Z-1469-2026, Z-1471-2026
- Impella RP Flex with SmartAssist. Product Code: 1000323.
- Impella RP with SmartAssist. Product Code: 0046-0035.
- Impella RP. Product Code: 0046-0011.
Ongoing Class II Medical devices
- Recall started
- 4 December 2025
- Reason
- Device packaged in incorrect outer box carton.
- Distribution
- International distribution to the country of Australia and Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1030-2026
- Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Ongoing Class I Medical devices
- Recall started
- 1 October 2025
- Reason
- Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
- Distribution
- Nationwide distribution. International distribution to United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Colombia, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom of Great Britain and Northern Ireland, Greece, Hong Kong, Croatia, Ire
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0069-2026
- Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Contro
Ongoing Class I Medical devices
- Recall started
- 16 September 2025
- Reason
- Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
- Distribution
- Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isreal, Italy, Japan, Kuwait, Luxembourg, Mexico, Netherlands, Pakistan, Panama, Poland, Saudi Arabia, Singapore, Spain, Sweden
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0136-2026
- Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201.
Ongoing Class I Medical devices
- Recall started
- 20 August 2025
- Reason
- Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
- Distribution
- US distribution to AR, AZ, CA, CO, CT, FL, GA, ID, MA, MI, MO, MS, NJ, NY, OH, PA, TX. International distribution to Canada, Germany, Great Britian, Italy, Netherlands, Norway.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2568-2025
- Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Pr
Ongoing Class I Medical devices
- Recall started
- 23 June 2025
- Reason
- A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
- Distribution
- Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei Darussalam, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2164-2025
- Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Co
Ongoing Class I Medical devices
- Recall started
- 12 December 2024
- Reason
- Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
- Distribution
- Domestic: Nationwide Distribution International: Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0830-2025, Z-0829-2025
- Impella RP Flex with SmartAssist; Product Number: 1000323;
- Impella RP with SmartAssist; Product Number: 0046-0035;
Ongoing Class II Medical devices
- Recall started
- 5 August 2024
- Reason
- A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2967-2024, Z-2957-2024, Z-2966-2024, Z-2964-2024, Z-2961-2024, Z-2960-2024, Z-2969-2024, Z-2970-2024, Z-2965-2024, Z-2955-2024, Z-2958-2024, Z-2971-2024 and 6 more
- ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
- Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
- Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
- Pump 381 Pump Set (US); Product Code: 1000080;
- Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
- Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
- Impella CP Smart Assist Set; Product Code: 1000402;
- Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
- and 10 more product lines
Ongoing Class I Medical devices
- Recall started
- 31 May 2024
- Reason
- Nine (9) Impella CP pumps failed inspection and were inadvertently released.
- Distribution
- Domestic only: FL, MA, OH TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2319-2024
- Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Ongoing Class II Medical devices
- Recall started
- 27 December 2023
- Reason
- New warnings are being added to the Instructions for Use for all affected products to reduce the possibility of fibers being drawn into the Impella, which may result in low flow of the device.
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1074-2024
- Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4)
Ongoing Class I Medical devices
- Recall started
- 27 December 2023
- Reason
- IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR, IN, MX, TW, and VI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0980-2024
- Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD
Ongoing Class II Medical devices
- Recall started
- 6 December 2023
- Reason
- The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature
- Distribution
- Domestic distribution nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0636-2024
- Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
Ongoing Class II Medical devices
- Recall started
- 7 November 2023
- Reason
- Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
- Distribution
- Nationwide Foreign: Country AT AU BE BR CA CA CH CZ DE DK ES FR FR HK IN IT MX MY NL NO PA SG TW UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0652-2024, Z-0653-2024, Z-0646-2024, Z-0651-2024, Z-0648-2024, Z-0650-2024, Z-0647-2024, Z-0655-2024, Z-0649-2024, Z-0654-2024
- Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046
- Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
- Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011,
- Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-0053
- Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015
- Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052
- Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
- Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 10 October 2023
- Terminated
- 6 March 2025
- Reason
- Pump not detected as connected to controller due to software issue.
- Distribution
- US: AZ, CA, FL, NY & VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0441-2024, Z-0440-2024
- Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
- Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Ongoing Class I Medical devices
- Recall started
- 29 June 2023
- Reason
- A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis
- Distribution
- US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA, MI, MO, NC, NJ, NY, OH, OR, SC, TX, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2281-2023
- Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Ongoing Class I Medical devices
- Recall started
- 14 June 2023
- Reason
- There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
- Distribution
- Worldwide distribution - US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2113-2023, Z-2112-2023, Z-2116-2023, Z-2111-2023, Z-2115-2023, Z-2114-2023
- Impella LD intravascular micro axial blood pump, Product Number 005082
- Impella 5.0 intravascular micro axial blood pump, Product Number 005062
- Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
- Impella 2.5 intravascular micro axial blood pump, Product Number 005042
- Impella CP intravascular micro axial blood pump, Product Number 0048-0032
- Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
Ongoing Class II Medical devices
- Recall started
- 26 May 2023
- Reason
- There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.
- Distribution
- US Nationwide distribution in the states of MN, NJ, TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2128-2023
- Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Ongoing Class I Medical devices
- Recall started
- 17 April 2023
- Reason
- The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
- Distribution
- US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, Germany
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1590-2023
- Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008
Terminated Class I Medical devices
- Recall started
- 14 December 2021
- Terminated
- 28 February 2023
- Reason
- The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a patient on support. Disruption of therapy could lead to prolonged hypoxia.
- Distribution
- US distribution to FL, GA, IN, MD, NC, PA, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0550-2022
- OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is s
Terminated Class II Medical devices
- Recall started
- 1 March 2021
- Terminated
- 6 March 2025
- Reason
- Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1175-2024
- Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Terminated Class II Medical devices
- Recall started
- 4 September 2019
- Terminated
- 21 January 2020
- Reason
- This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.
- Distribution
- The product was distributed to GA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0345-2020
- lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
Ongoing Class II Medical devices
- Recall started
- 19 February 2019
- Reason
- Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.
- Distribution
- Worldwide - US Nationwide and the countries of Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Luxembourg, Poland, Spain, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3251-2026
- Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Produc
Ongoing Class I Medical devices
- Recall started
- 17 January 2011
- Reason
- Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Denmark, France, Germany, Italy, Kuwait, Netherlands, Norway, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2238-2026
- Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.