FDA-Device2018-02-14Class II
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Hazard
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
Sold states
DE, IA, CA and Japan
Affected count
2914 units
Manufactured in
7611 Northland Dr N, N/A, Brooklyn Park, MN, United States
Products
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0535-2018More Medtronic Perfusion Systems recalls
- FDA-Device2026-07-22Medtronic Bio-Medicus Adult Cannula Kit recalled for loose foreign material with blood
- FDA-Device2026-07-22Medtronic DLP One-Piece Pediatric Arterial Cannula recalled for loose foreign material with blood
- FDA-Device2026-07-01Medtronic Octopus Evolution AS Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Medtronic Octopus 4 Tissue Stabilizer recalled for reversed tubing assembly
- FDA-Device2026-07-01Medtronic Octopus Evolution Tissue Stabilizer recalled for incorrect tubing assembly
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