Home › Device types › KRI
Accessory Equipment, Cardiopulmonary Bypass
FDA product code KRI · Class 1 · Cardiovascular
277
Registered devices
17
Adverse events
8
Recalls
42
510(k) clearances
Devices with this code
Bracket — LIVANOVA USA, INC.Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems CorporationCentriMag™ — Thoratec CorporationSurge Cardiovascular — Med Michigan Holdings, LLCCONNECTOR, Y 1/4" X 1/2" X 1/2" W/LUER — NOVOSCI CORP.CAPIOX — TERUMO CORPORATIONCDI™ Blood Parameter Monitoring System 550 — Terumo Cardiovascular Systems CorporationMillennium — Avalign Technologies, Inc.Surge Cardiovascular — Med Michigan Holdings, LLCSurge Cardiovascular — Med Michigan Holdings, LLCEOS BRACKET — SORIN GROUP ITALIA SRLTandemLung LifeSPARC — CARDIACASSIST, INC.TandemLife — CARDIACASSIST, INC.Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems CorporationBracket — LIVANOVA USA, INC.Bracket — LIVANOVA USA, INC.NA — Maquet Cardiopulmonary AGHOLDER — EUROSETS SRLBracket — LIVANOVA USA, INC.CONNECTOR, Y 1/4" X 3/8" X 3/8" W/LUER — NOVOSCI CORP.Bracket — LIVANOVA USA, INC.Sinergy and Mini Bag CPB — SORIN GROUP ITALIA SRLBracket — LIVANOVA USA, INC.PROTEK Duo — CARDIACASSIST, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-27 | Maquet Cardiopulmonary Gmbh | Device does not comply with the labeling requirements of international standard IEC 60601-1. |
| 2020-06-18 | Maquet Cardiovascular Us Sales, Llc | Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hol |
| 2018-04-04 | Maquet Cardiopulmonary Ag | There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations. |
| 2011-08-12 | Terumo Cardiovascular Systems Corporation | Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case. |
| 2011-03-01 | Terumo Cardiovascular Systems Corp | Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line |
| 2009-12-14 | Medtronic Inc | Medtronic has identified a small number of Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates (UBD) on the outer kit p |
| 2009-12-14 | Medtronic Inc | Medtronic has identified a small number of Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates (UBD) on the outer kit p |
| 2009-10-02 | Terumo Cardiovascular Systems Corporation | Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 i |
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