FDA recall Z-0535-2018

Medtronic Perfusion Systems · Class II · device

Product

Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.

Reason for recall

Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.

Distribution

DE, IA, CA and Japan

Key facts

Status
Terminated
Initiation date
2018-01-03
Report date
2018-02-14
Termination date
2020-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0535-2018