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Affinity™ CP CBAP40 (UDI 00613994647863)Recalls & reported problems

Medtronic, Inc. · PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994647863), received between Jul 28, 2023 and Jul 28, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 28, 2023Break; Break

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CENTRIFUGAL PUMP, IT WAS REPORTED THAT THE PUMP BLADE WAS BROKEN. SEE ATTACHED PHOTOS. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17412341 ↗

Other PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE devices

All PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.