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Custom Perfusion System
MEDTRONIC, INC. · Model CB3M07R4 · UDI-DI 00643169265752
KFM
Prescription
1
510(k) clearances
4,355
Adverse events (253 deaths)
40
Recalls
36
Facilities
Description
CUSTOM PACK CB3M07R4 CIRCUIT
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 pathogenic agents, resultin |
| 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 pathogenic agents, resultin |
| 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(k) cleared in the US |
| 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 94175452 affected by the i |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.