Affinity™ CP AP40 (UDI 00613994647849)Recalls & reported problems
Medtronic, Inc. · PUMP AP40 AFFINITY CP CENTRIFUGAL NC · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00613994647849), received between Jul 14, 2022 and Jul 14, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
- Noise, Audible1
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 14, 2022Material Deformation; Noise, Audible; Material Deformation; Noise, Audible
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AP 40 CENTRIFUGAL PUMP, THE CUSTOMER REPORTED THAT WHILE PRIMING THE PUMP, IT WAS OBSERVED THAT THE CONE HEAD WAS NOT SEATED PROPERLY WITHIN THE HOUSING, IT WAS RATTLING AND MAKING A LOUD NOISE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION STATING THAT THE PUMP WAS IN A CONSOLE AND THE SERIAL NUMBER OF CONSOLE IS UNKNOWN. THE NOISE WAS COMING FROM THE PUMP, THE PUMP WAS BEING PRIMED AND THE NOISE WAS NOTED RIGHT AWAY. THE CUSTOMER STATED THAT THERE WAS NO KNOWN DAMAGE TO THE PUMP. ANALYSIS OF THE RETURNED DEVICE FOUND DAMAGE TO THE PUMP IMPELLER. MEDTRONIC RECEIVED ADDITIONAL INFORMATION STATING THAT NO LEAK WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15011864 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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