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Medtronic Perfusion Systems Recalls
116 recalls on record · December 17, 2014 to August 5, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 29, 2025Medical DevicesFDA
Medtronic Perfusion Systems recalls DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Hazard: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
November 13, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Hazard: There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
September 18, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Hazard: 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).
July 31, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls TourniKwik Tourniquet Set (CFN 79012)
Hazard: Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
May 22, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr.
Hazard: Potential for unsealed sterile packing.
May 22, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tu
Hazard: Potential for unsealed sterile packing.
May 22, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.2
Hazard: Potential for unsealed sterile packing.
May 22, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in),
Hazard: Potential for unsealed sterile packing.
May 22, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009,
Hazard: Potential for unsealed sterile packing.
May 22, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009
Hazard: Potential for unsealed sterile packing.
May 22, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula
Hazard: Potential for unsealed sterile packing.
May 22, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourn
Hazard: Potential for unsealed sterile packing.
May 22, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent C
Hazard: Potential for unsealed sterile packing.
May 22, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001
Hazard: Potential for unsealed sterile packing.
May 22, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic DLP Coronary Ostial Cannulae, Model Number 30050
Hazard: Potential for unsealed sterile packing.
May 22, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Clearview Blower/Mister, Model Number 22120
Hazard: Potential for unsealed sterile packing.
May 22, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) D
Hazard: Potential for unsealed sterile packing.
March 27, 2024Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic DLP Vessel Cannula, Model Number REF 30000
Hazard: 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.
February 8, 2023Medical DevicesFDA
Medtronic Perfusion Systems recalls Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Bio
Hazard: 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.
February 8, 2023Medical DevicesFDA
Medtronic Perfusion Systems recalls Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Bio
Hazard: 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.
February 8, 2023Medical DevicesFDA
Medtronic Perfusion Systems recalls Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Car
Hazard: 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.
February 8, 2023Medical DevicesFDA
Medtronic Perfusion Systems recalls Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Car
Hazard: 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.
February 8, 2023Medical DevicesFDA
Medtronic Perfusion Systems recalls Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE
Hazard: 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.
February 8, 2023Medical DevicesFDA
Medtronic Perfusion Systems recalls Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Car
Hazard: 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.
June 1, 2022Medical DevicesFDA
Medtronic Perfusion Systems recalls Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plas
Hazard: Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
January 19, 2022Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM
Hazard: Product is labeled as non-pyrogenic but endotoxin testing was not performed.
December 1, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Cardioblate CryoFlex Surgical Ablation Console
Hazard: There is potential for intermittent electrical connectivity between the console and probe.
October 13, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Veno
Hazard: There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
September 29, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Hazard: Potential for a wire protrusion through the left heart vent catheter tip
September 29, 2021Medical DevicesFDA
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Hazard: Potential for a wire protrusion through the left heart vent catheter tip