Affinity™ CP BBAP40 (UDI 00643169855199)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169855199), received between Feb 1, 2023 and Feb 3, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 3, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE AFFINITY CENTRIFUGAL BLOOD PUMP EXHIBITED CLOTTING AND FLOW ISSUES. THE ISSUE WAS OBSERVED IN THE TOP PART OF THE CONE, WITH THE ISSUE WORSENING OVER TIME. THE PATIENT WAS ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) FOR 82 DAYS AND HAD BEEN USING THIS BIO-PUMP FOR 8 DAYS. ANTICOAGULANT THERAPY WITH BIVALIRUDIN WAS ADMINISTERED, AND ANTI-COAGULATION WAS ASSESSED USING ACT AND PARTIAL THROMBOPLASTIN TIME (PTT), WHICH WERE DOCUMENTED ON THE PATIENT CHART. THE PRIMING SOLUTION USED WAS SALINE, AND NO AIR ENTERED THE RESERVOIR RELATED TO TABLE MANNERS. PROTAMINE WAS NOT USED AS THIS WAS AN ECMO CASE. THE CLOT/FIBRIN GROWTH OCCURRED SUDDENLY, AND THERE WAS NO VENOUS RESERVOIR AS THIS WAS AN ECMO CASE. THE PUMP WAS NOT USED IN AN AP40AST AND NO CLAMPED LINES WERE PRESENT IN THE CIRCUIT. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS BECAUSE OF THE ISSUE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT'S TEMPERATURE WAS 36 TO 37.2. THE PCO2 (PARTIAL PRESSURE OF CARBON DIOXIDE) AND PO2 (PARTIAL PRESSURE OF OXYGEN) WAS 35MMHG AND 381MMHG POST OXYGENATOR, RESPECTIVELY. SWEEP WAS REDUCED FROM 7L/MIN TO 6L/MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245190 ↗
• MalfunctionJul 25, 2023Break; Noise, Audible; Break; Noise, Audible

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AP40 CENTRIFUGAL PUMP, IT WAS REPORTED THAT THE PUMP HEAD MADE NOISE WHILE PRIMING. IT WAS THEN NOTED THAT THE BEARING WAS BROKEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING. NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGED. THERE WAS NO BROKEN PORT. THERE WAS NO AP40 DRIVE. THERE WAS NO LEAK NOTED WITH THE DEVICE. THE NOISE STARTED IMMEDIATELY DURING PRIMING OF THE CIRCUIT. THE PUMP HAD BEEN IN USE FOR 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388091 ↗
• MalfunctionJul 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE (THE PATIENT WAS ON FEM-FEM VA EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND IMPELLA FOR SUPPORT) OF A MC3 NAUTILUS OXYGENATOR, THERE WAS DIFFICULTY MAINTAINING FLOW ABOVE 0.25 L/MIN AFTER ~5 HOURS OF USE. THE MEDTRONIC AP40 PUMP AND MEDTRONIC CIRCUIT (PART NUMBER BB9E78R4 L/T SPRT) WAS CHANGED OUT FOR A CARDIOHELP CIRCUIT AND THE FLOW IMPROVED TO 3.5-4.0 L/MIN. IT WAS SUSPECTED THAT THE NAUTILUS CLOTTED OFF. PATIENT EXPIRED LATER IN DAY; THE CUSTOMER WAS UNABLE TO CONCLUDE IF THIS OCCURRENCE WAS RELATED TO THE PATIENT DEATH. ADDITIONAL DETAILS: DRAINAGE: 24 EDWARDS (L FEM), RETURN: 19 EDWARDS (L FEM). SUPPORT WAS INITIATED 1:20 AM, W/5,000 HEPARIN, Q: 4.3, RPM: 3070, IMPELLA REMAINED. AN ABRUPT DROP IN FLOW AROUND 6:00 AM. UNABLE TO MAINTAIN FLOW ABOVE 0.25L/MIN, DIFFICULT DRAW ON POST-MEMBRANE SAMPLE PORT AND HIGH FLOW DRAW ON PRE-MEMBRANE SAMPLE AT 6:40 AM, Q: 0.25 L/MIN, RPM: 3665 AND AP-40 FELT ¿HOT¿- NO GRINDING FEEL/NOISE. CIRCUIT WAS CHANGED TO CARDIOHELP, (CANNULA WAS NOT CHANGED OUT) AT 7:00 AM, Q: 4.0, RPM: 3665, PT: 22 INR: 2.1 APTT: 90.2. PATIENT REMAINED STABLE, BUT EXPIRED LATER IN THE DAY. PRE/POST MEMBRANE PRESSURES A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17323898 ↗
• MalfunctionFeb 1, 2023Contamination; Obstruction of Flow; Contamination; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A CUSTOM TUBING PACK AND CENTRIFUGAL PUMP, THE CUSTOMER REPORTED AN ISSUE WITH THE EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT. IT WAS PREVIOUSLY PRIMED ON 22 DEC 2022 AND READY FOR TRANSPLANT ON (B)(6) 2023). THE CUSTOM TUBING PACK WAS CHECKED OVER AND THE CUSTOMER STATED THAT ALL LOOKED GOOD, AND THEY RECIRCULATED FOR 30 MINUTES WITH THE HEATER ON WITH NO ISSUES. IT WAS THEN TURNED OFF UNTIL CLOSER TO HANDING UP THE LINES AND WHEN THE DEVICE WAS TURNED BACK ON IT WAS FINE INITIALLY BUT THEN THE CUSTOMER NOTICED WHITE FOREIGN MATERIAL (FM) FLOATING THROUGH THE CIRCUIT AND THE FLOWS DROPPED FROM 4.5LPM AT 1700 RPM DOWN TO 0.2 LPM. THE CUSTOMER MENTIONED THAT THE FM LOOKED LIKE PIECES OF THE MEMBRANE FIBERS FLOATING IN THE BAG AND NOTHING ELSE WAS ADDED TO THE CIRCUIT / PRIME. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE HEALTH CARE PROFESSIONAL BELIEVES THAT THE PARTICLES LOOK LIKE MEMBRANE FIBERS AND THEREFORE SUSPECT IT IS RELATED TO THE MAQUET OXYGENATOR VERSUS THE MEDTRONIC PRODUCTS. THE FOREIGN MATERIAL WAS LOCATED FLOATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16276609 ↗