Brooklyn Park, MN, United States
Medtronic Perfusion Systems recalls
31 recalls recorded since 2018, most recently on 24 June 2026. 24 are listed as ongoing. Status and classification are as published by the FDA.
Recalls31
Ongoing (FDA)24
Terminated or completed7
Class I (FDA)4
Ongoing Class II Medical devices
- Recall started
- 24 June 2026
- Reason
- Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2809-2026, Z-2811-2026, Z-2810-2026, Z-2806-2026, Z-2808-2026, Z-2807-2026
- EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
- EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
- EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
- EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
- EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
- EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
Ongoing Class II Medical devices
- Recall started
- 25 May 2026
- Reason
- Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
- Distribution
- Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2739-2026, Z-2738-2026
- Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
- Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Ongoing Class II Medical devices
- Recall started
- 12 May 2026
- Reason
- During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2576-2026, Z-2577-2026, Z-2575-2026
- Octopus Evolution AS Tissue Stabilizer, Model TS2500
- Octopus 4 Tissue Stabilizer, Model 29400
- Octopus Evolution Tissue Stabilizer, Model TS2000
Ongoing Class II Medical devices
- Recall started
- 21 April 2026
- Reason
- Certain lots of product have the potential for a sterile barrier breach.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, S
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2218-2026, Z-2219-2026, Z-2216-2026, Z-2214-2026, Z-2217-2026, Z-2221-2026, Z-2222-2026, Z-2220-2026, Z-2215-2026
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter
- Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
- Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter
- and 1 more product lines
Ongoing Class II Medical devices
- Recall started
- 13 January 2026
- Reason
- During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
- Distribution
- US Nationwide. Global Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1473-2026
- Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Ongoing Class II Medical devices
- Recall started
- 20 October 2025
- Reason
- Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
- Distribution
- US Nationwide distribution in the states of Hawaii and New York.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0539-2026
- Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Ongoing Class II Medical devices
- Recall started
- 3 October 2025
- Reason
- As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0509-2026
- MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
Ongoing Class II Medical devices
- Recall started
- 12 September 2025
- Reason
- Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
- Distribution
- US States: AZ, CA, TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0487-2026
- Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Ongoing Class I Medical devices
- Recall started
- 6 August 2025
- Reason
- The catheters may not retain their shape.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2481-2025, Z-2482-2025, Z-2480-2025
- DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
- DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
- DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Ongoing Class I Medical devices
- Recall started
- 5 February 2025
- Reason
- Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).
- Distribution
- Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bosnia And Herzegovina Botswana Brazil Bulgaria Canada Canary Islands Cayman Islands Chile China Colombia Costa R
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1306-2025
- Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA, model no. 11014 2. MiAR Cannula: A. CANNULA 11012L AR FLOWGUARD LONG 12GA, m
Ongoing Class II Medical devices
- Recall started
- 12 December 2024
- Reason
- Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0984-2025, Z-0985-2025, Z-0986-2025
- DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
- EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
- Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Ongoing Class II Medical devices
- Recall started
- 3 October 2024
- Reason
- There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
- Distribution
- US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0289-2025
- Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Ongoing Class II Medical devices
- Recall started
- 9 July 2024
- Reason
- During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).
- Distribution
- Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3128-2024
- Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Ongoing Class II Medical devices
- Recall started
- 16 May 2024
- Reason
- Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
- Distribution
- Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2423-2024
- TourniKwik Tourniquet Set (CFN 79012)
Ongoing Class II Medical devices
- Recall started
- 19 March 2024
- Reason
- Potential for unsealed sterile packing.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1802-2024, Z-1799-2024, Z-1803-2024, Z-1797-2024, Z-1801-2024, Z-1795-2024, Z-1804-2024, Z-1796-2024, Z-1798-2024, Z-1794-2024, Z-1800-2024, Z-1793-2024 and 1 more
- Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000
- Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 30003
- Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model
- Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., Model Number 12008, c) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12001,
- Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP¿ 30
- Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
- Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10052, c) DLP¿ Suction Tube 6-Fr. Shaft with 1
- Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
- and 5 more product lines
Ongoing Class II Medical devices
- Recall started
- 7 February 2024
- Reason
- Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
- Distribution
- US and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1316-2024
- Medtronic DLP Vessel Cannula, Model Number REF 30000
Ongoing Class II Medical devices
- Recall started
- 12 December 2022
- Reason
- An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
- Distribution
- Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Den
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1028-2023, Z-1023-2023, Z-1024-2023, Z-1026-2023, Z-1027-2023, Z-1025-2023
- Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
- Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
- Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
Ongoing Class II Medical devices
- Recall started
- 20 April 2022
- Reason
- Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, ND, MA, ID, WI, KS, UT, MN, NY, NJ, GA, MO and the countries of Australia, Belgium, China, Czech Republic, France, Germany, Greece, Israel, Italy, Kazakhstan, Latvia, Netherlands, Poland, Russian Federation, Singapore, Switzerl
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1131-2022
- Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 ca
Ongoing Class II Medical devices
- Recall started
- 12 October 2021
- Reason
- Product is labeled as non-pyrogenic but endotoxin testing was not performed.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CT, IL, IN, KY, MA, ME, MS, NY, OH, RI, TN, TX, and VA. The countries of Canada, Columbia, France, Germany, Italy, Netherlands, Saudi Arabia, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0491-2022
- Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R);
Ongoing Class II Medical devices
- Recall started
- 27 September 2021
- Reason
- There is potential for intermittent electrical connectivity between the console and probe.
- Distribution
- Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0273-2022
- Cardioblate CryoFlex Surgical Ablation Console
Ongoing Class II Medical devices
- Recall started
- 13 September 2021
- Reason
- There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0003-2022
- Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Ongoing Class II Medical devices
- Recall started
- 24 August 2021
- Reason
- Potential for a wire protrusion through the left heart vent catheter tip
- Distribution
- Nationwide distribution to AL, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI. International distribution to Albania, Algeria, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, C
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2505-2021, Z-2504-2021
- DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
- DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Terminated Class II Medical devices
- Recall started
- 29 April 2021
- Terminated
- 20 March 2023
- Reason
- Specific lots may have been manufactured with insufficient or incomplete welds.
- Distribution
- US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1890-2021, Z-1891-2021, Z-1882-2021, Z-1879-2021, Z-1892-2021, Z-1873-2021, Z-1889-2021, Z-1881-2021, Z-1887-2021, Z-1871-2021, Z-1876-2021, Z-1874-2021 and 13 more
- Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
- Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
- Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
- Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
- Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
- Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
- Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
- Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
- and 17 more product lines
Ongoing Class I Medical devices
- Recall started
- 3 March 2021
- Reason
- An electrical component within the system controller module of certain Bio-Console 560 devices may exhibit electrical failure causing the device to stop pumping. Issues observed include the pump stopping, the user interface going blank, and smoking and producing a burning odor during use.
- Distribution
- Worldwide distribution. US Nationwide including Puerto Rico, Brazil, Brunei Darussalam, Canada, China, Colombia, Croatia, Ecuador, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Korea, Mexico, Morocco, New Zealand, Russian Federation, Spain, Taiwan, Thailand, United Kingdom, and Viet Nam
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1313-2021
- Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.
Terminated Class I Medical devices
- Recall started
- 4 February 2021
- Terminated
- 26 April 2024
- Reason
- Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
- Distribution
- Worldwide distribution: US nationwide, Afghanistan, Argentina, Chile, China, Colombia, Egypt, Germany, Iraq, Italy, Japan, Korea, Kyrgyzstan, Latvia, Nicaragua, Paraguay, Poland, Qatar, Romania, Tanzania, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1193-2021, Z-1198-2021, Z-1197-2021, Z-1192-2021, Z-1199-2021, Z-1195-2021, Z-1191-2021, Z-1196-2021, Z-1190-2021, Z-1194-2021
- Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and s
- Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during
- Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood
- Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorpore
- Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal ci
- Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extra
- Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance B
- Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circul
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 14 November 2019
- Terminated
- 5 October 2020
- Reason
- Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
- Distribution
- CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0693-2020
- Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Ongoing Class II Medical devices
- Recall started
- 27 November 2018
- Reason
- Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0786-2019, Z-0785-2019
- SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
- RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
Terminated Class II Medical devices
- Recall started
- 8 August 2018
- Terminated
- 6 October 2020
- Reason
- Affected products failed a sterilization test.
- Distribution
- Domestic Distribution only to CA and MI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2495-2020
- Extra corporeal circuit with bio-active surface.
Terminated Class II Medical devices
- Recall started
- 8 February 2018
- Terminated
- 6 August 2020
- Reason
- Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning protocol will not be developed by Medtronic and it has been determined that the best course of action is to request BIO CAL users to discontinue use and dispose of BIO CAL devices.
- Distribution
- Worldwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0900-2018
- BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures wh
Terminated Class II Medical devices
- Recall started
- 16 January 2018
- Terminated
- 21 August 2020
- Reason
- Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.
- Distribution
- Worldwide Distribution - US Distribution and to the countries of : Australia, Canada, Colombia, Denmark, Germany, Guyana, Israel, Italy, Japan, Netherlands, Norway, Saudi Arabia and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0645-2018, Z-0646-2018
- Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorpor
- Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and
Terminated Class II Medical devices
- Recall started
- 3 January 2018
- Terminated
- 5 October 2020
- Reason
- Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
- Distribution
- DE, IA, CA and Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0535-2018
- Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
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.