Medtronic Perfusion Systems
24 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Medtronic Perfusion Systems and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-09-10FDA-DeviceClass IDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
The catheters may not retain their shape.
- 2025-09-10FDA-DeviceClass IDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
The catheters may not retain their shape.
- 2025-09-10FDA-DeviceClass IDLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
The catheters may not retain their shape.
- 2025-03-19FDA-DeviceClass IAortic 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 Vent Line A. CANNULA 21012 AR VENT FLOW 12GA, model no. 21012 B. CANNULA 21014 AR VENT FLOW 14GA, model no. 21014
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).
- 2025-01-29FDA-DeviceClass IISelect Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- 2025-01-29FDA-DeviceClass IIEOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- 2025-01-29FDA-DeviceClass IIDLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- 2024-11-13FDA-DeviceClass IIMedtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
- 2024-09-18FDA-DeviceClass IIMedtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
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).
- 2024-07-31FDA-DeviceClass IITourniKwik Tourniquet Set (CFN 79012)
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
- 2024-05-22FDA-DeviceClass IIMedtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP¿ 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP¿ 30 Fr. Malleable Single Stage Venous Cannula, Model Number 68130, e) DLP¿ 34 Fr. Malleable Single Stage Venous Cannula, Model Number 68134, f) DLP¿ 12 Fr. Single Stage Venous Cannula, Model Number 67312, g) DLP¿ 16 Fr. Single St
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceClass IIMedtronic 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 10-Fr. Soft Tip, Model Number: 10053, d) DLP¿ Suction Tube 10 Fr. Shaft with 20 Fr. Pool Tip, Model Number: 10060, e) DLP¿ Suction Tube 16 Fr. Shaft with 20 Fr. Fluted Tip, Model Number: 10061
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceClass IIMedtronic 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 Numbers: 31200
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceClass IIMedtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceClass IIMedtronic 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¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003, d) DLP¿ 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000, e) DLP¿ 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G, f) DLP¿ Perfusion/Venting Adapter, Model Number 13002, g) DLP¿ Y Adapter
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceClass IIMedtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceClass IIMedtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 30003
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceClass IIMedtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model Number 79009
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceClass IIMedtronic 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, d) DLP¿ Left Heart Vent Catheter 13 Fr., Model Number 12113, e) DLP¿ Left Heart Vent Catheter 16 Fr., Model Number 12016, f) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12002, g) DLP¿ Left Heart Vent Catheter 20 Fr. Model Number 12220, h) DLP¿ Pericardial Sump 38
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceClass IIMedtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceClass IIMedtronic DLP Coronary Ostial Cannulae, Model Number 30050
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceClass IIMedtronic Clearview Blower/Mister, Model Number 22120
Potential for unsealed sterile packing.
- 2024-05-22FDA-DeviceClass IIMedtronic 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 87120; e) DLP¿ Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 80222; f) DLP¿ Curved Metal Tip Arterial Cannula 22 Fr. , Model Number 87122; g) DLP¿ Curved Tip Art
Potential for unsealed sterile packing.
- 2024-03-27FDA-DeviceClass IIMedtronic DLP Vessel Cannula, Model Number REF 30000
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.
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