Miami Lakes, FL, United States
Heartware, Inc. recalls
19 recalls recorded since 2018, most recently on 31 October 2023. 16 are listed as ongoing. Status and classification are as published by the FDA.
Recalls19
Ongoing (FDA)16
Terminated or completed3
Class I (FDA)8
Ongoing Class II Medical devices
- Recall started
- 31 October 2023
- Reason
- Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0478-2024, Z-0482-2024, Z-0481-2024, Z-0475-2024, Z-0479-2024, Z-0483-2024, Z-0476-2024, Z-0477-2024, Z-0480-2024
- PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
- PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
- PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
- PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
- STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
- and 1 more product lines
Ongoing Class II Medical devices
- Recall started
- 16 May 2023
- Reason
- Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.
- Distribution
- Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1993-2023
- HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
Ongoing Class II Medical devices
- Recall started
- 29 November 2022
- Reason
- Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0742-2023, Z-0747-2023, Z-0743-2023, Z-0745-2023, Z-0746-2023, Z-0750-2023, Z-0744-2023, Z-0749-2023, Z-0748-2023
- HeartWare Model 1100
- HeartWare HVAD Pump Kit, REF 1104CA-CLIN
- HeartWare Model 1101
- HeartWare HVAD Pump Kit, REF 1103
- HeartWare HVAD Pump Kit, REF 1104
- HeartWare HVAD Pump Kit, REF MCS1705PU
- HeartWare Model 1102
- HeartWare HVAD Pump Kit, REF 1205
- and 1 more product lines
Ongoing Class I Medical devices
- Recall started
- 28 June 2022
- Reason
- Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
- Distribution
- Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Sweden, Norway, Denmark, Estonia, Lebanon, Croatia, Spain, Austria, United Arab Emirat
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1512-2022
- HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Ongoing Class II Medical devices
- Recall started
- 30 March 2022
- Reason
- Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- Distribution
- Finland and Turkey
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1103-2022, Z-1106-2022, Z-1104-2022, Z-1105-2022, Z-1107-2022, Z-1102-2022
- HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
- HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
- HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
- HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
- HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide
- HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Ongoing Class II Medical devices
- Recall started
- 27 January 2022
- Reason
- Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.
- Distribution
- Distribution throughout the United States. OUS distribution in Argentina, Armenia, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea (So
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0726-2022
- HeartWare Ventricular Assist Device (HVAD) System
Ongoing Class II Medical devices
- Recall started
- 6 August 2021
- Reason
- There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.
- Distribution
- Distribution throughout the US. Also distribution in ARGENTINA Armenia, Australia, Austria, BELGIUM, BRAZIL, CANADA, CHILE, Colombia, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, Germany, GREECE HONG KONG, HUNGARY, INDIA, ISRAEL, Italy, JAPAN, Kazakhstan, Korea, KUWAIT, La
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2478-2021
- Medtronic HVAD Pump Implant Kits
Ongoing Class I Medical devices
- Recall started
- 3 June 2021
- Reason
- Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.
- Distribution
- Worldwide distribution. US nationwide and Armenia, AUSTRIA, Bahrain, Belgium, CROATIA, CZECH REPUBLIC, Denmark, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, Hungary, Israel, ITALY, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, LITHUANIA, LUXEMBOURG, Macedonia, NETHERLANDS, Norway, POLAND, Qatar
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2190-2021, Z-2191-2021, Z-2196-2021, Z-2197-2021, Z-2192-2021, Z-2188-2021, Z-2189-2021, Z-2194-2021, Z-2193-2021, Z-2195-2021
- HeartWare HVAD Pump Implant Kit, REF 1125
- HeartWare HVAD Pump Implant Kit, REF 1153
- HeartWare HVAD Outflow Graft, REF MCS1725OG
- HeartWare HVAD Pump Accessories, REF MCS1753AK
- HeartWare HVAD Driveline Extension Cable, REF 100
- HeartWare HVAD Pump Implant Kit, REF 1103
- HeartWare HVAD Pump Implant Kit, REF 1104
- HeartWare HVAD Implant Kit, REF 1104JP
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 28 May 2021
- Terminated
- 22 September 2026
- Reason
- The pump has an impeller with a shroud height that did not meet the lower control limit.
- Distribution
- International distribution to the country of Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2072-2021
- HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT)
Ongoing Class II Medical devices
- Recall started
- 26 February 2021
- Reason
- IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Italy, Great Britain, Germany, Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1438-2021
- Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD contr
Ongoing Class II Medical devices
- Recall started
- 26 February 2021
- Reason
- IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean there is an intermittent problem and the cause of the alarm can be evaluated by analysis of the controller log files. The Patient Manual (PM) is being updated to instruct patients to contact their clinicians if they cannot identify an alarm before it is cleared as it might mean there is an intermittent problem. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87604
- Distribution
- Worldwide distribution, including: US nationwide, Italy, Great Britain, Germany, Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1469-2021
- Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controlle
Ongoing Class I Medical devices
- Recall started
- 26 February 2021
- Reason
- There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1336-2021, Z-1340-2021, Z-1339-2021, Z-1337-2021, Z-1338-2021, Z-1341-2021
- Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB
- Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
- Medtronic HVAD Monitor Data Cable, Product Number: 1575
- Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US
- Medtronic HVAD Alarm Adapter, Product Number: 1450
- Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP
Ongoing Class I Medical devices
- Recall started
- 26 February 2021
- Reason
- Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and Controller Power Up Sequence issues. The PM is being updated to clarify use of the support strap and wear instructions in addition to cleaning instructions of the carrying cases. The IFU and PM are being updated to add a useful life for the carrying cases. The PM is being updated to inform users to keep the driveline cover on when disconnecting and reconnecting the driveline. The IFU and PM are being updated to clarify the power-up sequence that causes the alarm indicator LEDs and both sets of battery LEDs to turn red for 2.5 seconds while the LCD displays the power-on message. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87603 and 87604
- Distribution
- Worldwide distribution: US (nationwide) and countries of: ARGENTINA, Armenia, Australia, AUSTRIA, Bahrain, BELGIUM, Brazil, CANADA, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, FINLAND, France, GERMANY, Greece, Hong Kong, Hungary, INDIA, Israel, Italy, Japan, Kazakhstan, Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1426-2021
- Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Ki
Ongoing Class I Medical devices
- Recall started
- 19 November 2020
- Reason
- Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.
- Distribution
- Worldwide - US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0946-2021
- Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU
Ongoing Class I Medical devices
- Recall started
- 3 April 2020
- Reason
- The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2055-2020, Z-2058-2020, Z-2056-2020, Z-2057-2020, Z-2059-2020
- Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
- Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
- Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
- Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
- Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
Ongoing Class I Medical devices
- Recall started
- 23 January 2020
- Reason
- Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
- Distribution
- No affected devices distributed within the US. International distribution to Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, EGYPT, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Korea, Korea, Republic o
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1427-2020, Z-1428-2020
- HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation
- HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Trans
Terminated Class II Medical devices
- Recall started
- 19 November 2018
- Terminated
- 21 July 2020
- Reason
- HVAD Battery Charger units manufactured with wrong inductors.
- Distribution
- Worldwide distribution - US nationwide distribution in the state of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI. Countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Estonia, Fi
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0582-2019
- Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a
Terminated Class II Medical devices
- Recall started
- 28 August 2018
- Terminated
- 5 April 2019
- Reason
- Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0067-2019
- Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory le
Ongoing Class I Medical devices
- Recall started
- 2 May 2018
- Reason
- Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.
- Distribution
- Worldwide Distribution including US Nationwide, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea, , Kuwait, Latvia, Le
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1903-2018
- Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adap
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.