Home / Recalls / Medical Devices
Medtronic Perfusion Systems recalls Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB)
Recalled February 14, 2018 · FDA recall Z-0535-2018 · Medtronic Perfusion Systems
Hazard
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve. · FDA Class II
Units
2914 units
Sold at
DE, IA, CA and Japan
Description
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
Product
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →