Home › Device types › KFM
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
FDA product code KFM · Class 2 · Cardiovascular
1,811
Registered devices
4,355
Adverse events
40
Recalls
84
510(k) clearances
Devices with this code
Custom Perfusion System — MEDTRONIC, INC.Intersept® Custom Tubing Pack — MEDTRONIC, INC.Custom Perfusion System — MEDTRONIC, INC.Custom Perfusion System — MEDTRONIC, INC.NA — MEDTRONIC, INC.Custom Perfusion System — MEDTRONIC, INC.Custom Perfusion System — MEDTRONIC, INC.NA — MEDTRONIC, INC.Custom Perfusion System — MEDTRONIC, INC.Custom Perfusion System — MEDTRONIC, INC.Custom Perfusion System — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.Custom Perfusion System — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.Custom Perfusion System — MEDTRONIC, INC.Intersept® Custom Tubing Pack — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — MEDTRONIC, INC.Custom Perfusion System — MEDTRONIC, INC.Custom Perfusion System — MEDTRONIC, INC.Custom Perfusion System — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-16 | Spectrum Medical Inc | Their is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures. |
| 2024-01-08 | Maquet Medical Systems USA | Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathoge |
| 2024-01-08 | Maquet Medical Systems USA | Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathoge |
| 2023-06-30 | Cardiac Assist, Inc | Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure, |
| 2021-03-22 | QURA S.R.L. | Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510( |
| 2020-08-07 | Maquet Cardiovascular Us Sales, Llc | Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 941754 |
| 2020-03-06 | Cardiac Assist, Inc | Failure to prime due to an assembly error |
| 2020-03-06 | Cardiac Assist, Inc | Failure to prime due to an assembly error |
| 2020-03-06 | Cardiac Assist, Inc | Failure to prime due to an assembly error |
| 2020-03-06 | Cardiac Assist, Inc | Failure to prime due to an assembly error |
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