Quantum Perfusion Centrifugal Blood Pump CP37 CP37V-V0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08051160300617), received between Mar 26, 2025 and Aug 29, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  GOT AN URGENT CALL WHILE ON BYPASS ASKING IF THE MAX RPM'S FOR THE CP37 WAS 4000. COULD NOT FLOW ABOVE 2.5 LITERS WITH A NORMAL LINE PRESSURE. WENT ON FINE WITH NORMAL FLOWS BUT WHEN LOWERED THE FLOW TO APPLY THE CROSS CLAMP AND CAME BACK UP COULD NOT COME TO FULL FLOW. PROCEEDED TO HAND CRANK AND ACHIEVED NORMAL FLOW. SWITCHED MOTORS WITH SAME LOW FLOW HIGH RPM RESULTS. AFTER SEVERAL MINUTES THEY WERE ABLE TO COME UP TO A NORMAL FLOW. ACT WAS GOOD AND CLAMP WAS ALSO RE-ADJUSTED BUT DIDN'T HELP. I DISCUSSED WITH THEM THE POSSIBILITIES OF: 1. SEATING OF DISPOSABLE. 2. CLOT IMPEADING FLOW INTO THE PUMP HEAD. 3. PROBLEM WITH THEIR LINE PRESSURE TRANDSDUCER. 4. POSSIBLE PROBLEM WITH CIRCUIT BEFORE WHERE THEY MEASURE LINE PRESSURE.

  Patient problems: Reduced Blood Flow

  MAUDE report 22921738 ↗
• MalfunctionAug 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  CP37 PUMPHEAD CAVITATING SIGNIFICANT AIR DURING PRIMING. IT WAS DEAIRED MULTIPLE TIMES BUT IT CONTINUED TO ENTRAIN AIR. NO NOISE OR CRACKS/VISIBLE DAMAGE TO PUMPHEAD. PRESSURIZED CIRCUIT TO TEST FOR LEAK, BUT NO LEAK NOTED. SWAPPED OUT FOR NEW PUMPHEAD AND THE ISSUE DISAPPEARED.

  Patient problems: Air Embolism

  MAUDE report 22715133 ↗
• MalfunctionApr 10, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  CP37 PUMPHEAD CAVITATING SIGNIFICANT AIR DURING DE-AIRING OF PRIMED HLM. ATTEMPTS TO DE-AIR RESULTED IN TINY CHAMPAGNE BUBBLE FORMATION ORIGINATING FROM THE CENTRIFUGAL PUMP. NO NOISE OR CRACKS/VISIBLE DAMAGE TO PUMPHEAD. PRESSURIZED CIRCUIT TO TEST FOR LEAK, BUT NO LEAK NOTED. SWAPPED OUT FOR NEW PUMPHEAD AND THE ISSUE DISAPPEARED.

  Patient problems: Air Embolism

  MAUDE report 21811739 ↗
• MalfunctionMar 26, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  CP37 PUMPHEAD CAVITATING SIGNIFICANT AIR DURING PRIMING. IT WAS DEAIRED 3 TIMES BUT IT CONTINUED TO ENTRAIN AIR. NO NOISE OR CRACKS/VISIBLE DAMAGE TO PUMPHEAD. PRESSURIZED CIRCUIT TO TEST FOR LEAK, BUT NO LEAK NOTED. SWAPPED OUT FOR NEW PUMPHEAD AND THE ISSUE DISAPPEARED.

  Patient problems: Air Embolism

  MAUDE report 21695243 ↗