Medtronic Perfusion Systems recalls
11 recalls on record · 2 rated Critical · FDA
Every recall we have on record for Medtronic Perfusion Systems, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725;…
Certain lots of product have the potential for a sterile barrier breach.
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous…
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT…
The catheters may not retain their shape.
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA,…
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).
Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number…
Potential for unsealed sterile packing.
Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number…
Potential for unsealed sterile packing.
Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model…
Potential for unsealed sterile packing.
Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number…
Potential for unsealed sterile packing.
Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension…
Potential for unsealed sterile packing.
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated…
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.
Medtronic Custom Perfusion kits, with the following product descriptions and…
Product is labeled as non-pyrogenic but endotoxin testing was not performed.