Recall Z-0535-2018— Medtronic Perfusion Systems
Class II · Terminated
Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2018-01-03, terminated 2020-10-05. It names one FDA 510(k) clearance: K171308. Product: Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.. Reason: Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve..
- Recalling firm
- Medtronic Perfusion Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-03
- Terminated
- 2020-10-05
- Firm location
- Brooklyn Park, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.