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Medtronic Perfusion Systems

Medtronic Perfusion Systems Recalls

All product recalls associated with Medtronic Perfusion Systems.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–33 of 33 recalls

Medtronic Perfusion Systems: Medtronic Suction Tubes: a) DLP Suction Tube 6-Fr. Shaft...

Potential for unsealed sterile packing.

Moderate

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Medtronic Perfusion Systems: Medtronic Disposable Pressure Display Sets: a) DLP 114....

Potential for unsealed sterile packing.

Moderate

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Medtronic Perfusion Systems: Medtronic Aortic Root Cannulae and Cardioplegia Needles: ...

Potential for unsealed sterile packing.

Moderate

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Page 2 of 2Next

Medtronic Perfusion Systems: Medtronic DLP Coronary Ostial Cannulae, Model Number 30050

Potential for unsealed sterile packing.

Moderate

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Medtronic Perfusion Systems: Medtronic 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.

Moderate

FDAFeb 7, 2024GA• Medtronic Perfusion Systems

Medtronic Perfusion Systems: Custom Pack Perfusion Tubing Packs containing Affinity Fu...

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.

Moderate

FDADec 12, 2022Nationwide• Medtronic Perfusion Systems

Medtronic Perfusion Systems: Affinity Fusion Oxygenator with Integrated Arterial Filte...

Moderate

FDADec 12, 2022Nationwide• Medtronic Perfusion Systems

Medtronic Perfusion Systems: Cardioblate" Gemini"-s Irrigated RF Surgical Ablation Sys...

Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.

Moderate

FDAApr 20, 2022Nationwide• Medtronic Perfusion Systems

Medtronic Perfusion Systems: Medtronic Custom Perfusion kits, with the following produ...

Product is labeled as non-pyrogenic but endotoxin testing was not performed.

Moderate

FDAOct 12, 2021Nationwide• Medtronic Perfusion Systems

Medtronic Perfusion Systems: Cardioblate CryoFlex Surgical Ablation Console

There is potential for intermittent electrical connectivity between the console and probe.

Moderate

FDASep 27, 2021IL, IN, KS +1 more• Medtronic Perfusion Systems

Medtronic Perfusion Systems: Medtronic Bio-Medicus Insertion Kits, Model number 96553,...

There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

Moderate

FDASep 13, 2021Nationwide• Medtronic Perfusion Systems

Medtronic Perfusion Systems: DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only

Potential for a wire protrusion through the left heart vent catheter tip

Moderate

FDAAug 24, 2021Nationwide• Medtronic Perfusion Systems

Medtronic Perfusion Systems: Medtronic Bio-Console 560 Extracorporeal Blood Pumping Co...

Fire/Burn Risk

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.

Moderate

FDAMar 3, 2021Nationwide• Medtronic Perfusion Systems