Medtronic Perfusion Systems: FDA recalls

FDA enforcement reports name Medtronic Perfusion Systems as the recalling firm in 38 events. The events have 116 product records. The recalls started from 2014 to 2026. All the events are device recalls.

See the 38 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

38 events, newest first.

FDA enforcement events of Medtronic Perfusion Systems
Initiated	Product (first record)	Type	Class	Records	Status
24 Jun 2026	EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422	Device	Class II	6	Ongoing
25 May 2026	Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula	Device	Class II	2	Ongoing
12 May 2026	Octopus Evolution Tissue Stabilizer, Model TS2000	Device	Class II	3	Ongoing
21 Apr 2026	Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter	Device	Class II	9	Ongoing
13 Jan 2026	Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1	Device	Class II	1	Ongoing
20 Oct 2025	Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03	Device	Class II	1	Ongoing
3 Oct 2025	MC3 VitalFlow Console, REF 58100; Blood pump of ecmo	Device	Class II	1	Ongoing
12 Sep 2025	Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B	Device	Class II	1	Ongoing
6 Aug 2025	DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113	Device	Class I	3	Ongoing
5 Feb 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, model no 11012L B. CANNULA 11014L AR FLOWGUARD 14FR LONG, model no. 11014L 3. DLP Aortic Root Cannula with…	Device	Class I	1	Ongoing
12 Dec 2024	DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)	Device	Class II	3	Ongoing
3 Oct 2024	Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery	Device	Class II	1	Ongoing
9 Jul 2024	Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312	Device	Class II	1	Ongoing
16 May 2024	TourniKwik Tourniquet Set (CFN 79012)	Device	Class II	1	Ongoing
19 Mar 2024	Medtronic Arterial Cannulae packaged as: a) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLP Curved Metal Tip Arterial Cannula 20 Fr., Model Number…	Device	Class II	13	Ongoing
7 Feb 2024	Medtronic DLP Vessel Cannula, Model Number REF 30000	Device	Class II	1	Ongoing
12 Dec 2022	Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.	Device	Class II	6	Ongoing
20 Apr 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 carton per box.	Device	Class II	1	Ongoing
12 Oct 2021	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); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4. CUSTOM PACK BB7H95R25 HYP MAIN (Model BB7H95R25); 5.…	Device	Class II	1	Ongoing
27 Sep 2021	Cardioblate CryoFlex Surgical Ablation Console	Device	Class II	1	Ongoing
13 Sep 2021	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.	Device	Class II	1	Ongoing
24 Aug 2021	DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only	Device	Class II	2	Ongoing
29 Apr 2021	Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.	Device	Class II	25	Terminated
3 Mar 2021	Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures.	Device	Class I	1	Ongoing
4 Feb 2021	Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal…	Device	Class I	10	Terminated
14 Nov 2019	Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351	Device	Class II	1	Terminated
27 Nov 2018	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.	Device	Class II	2	Ongoing
8 Aug 2018	Extra corporeal circuit with bio-active surface.	Device	Class II	1	Terminated
8 Feb 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 when heating or cooling of the blood is desired.	Device	Class II	1	Terminated
16 Jan 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 extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de…	Device	Class II	2	Terminated
3 Jan 2018	Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.	Device	Class II	1	Terminated
22 Jun 2017	DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery	Device	Class II	5	Terminated
4 Feb 2016	Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the…	Device	Class III	1	Terminated
28 Oct 2015	Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal…	Device	Class II	1	Terminated
18 Aug 2015	MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.	Device	Class II	2	Terminated
24 Jul 2015	Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in duration.	Device	Class II	1	Terminated
12 Jun 2015	Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter transition from the dilator. The dilator…	Device	Class II	1	Terminated
31 Oct 2014	The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a…	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Medtronic Perfusion Systems: events for each product type
Type		Events
Device		38

Medtronic Perfusion Systems: events in each class
Class		Events
Class II		33
Class I		4
Class III		1

Share of the events of the firm in Class I: 11%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 24

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Medtronic Perfusion Systems, by the year that the recall started. The largest year is 2021, with 7 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Medtronic Perfusion Systems: FDA recalls. https://recallregister.com/firm/medtronic-perfusion-systems/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: MN

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Medtronic Perfusion Systems have?: Class II: 33 events. Class I: 4 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Medtronic Perfusion Systems?: FDA event 99320, which the firm started on 24 Jun 2026. The first product in the record is: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
How many FDA recalls of Medtronic Perfusion Systems have the status Ongoing?: 24 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.