Affinity CPRecalls & reported problems across all models

We found 6 models of Affinity CP by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Mar 30, 2020 and Feb 3, 2026 — classified as 3 deaths, 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Crack” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Affinity CP problems

Affinity CP models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Affinity™ CP AP40

  Pump, blood, cardiopulmonary bypass, non-roller type
  3 deaths11 reports
• Affinity™ CP BBAP40

  PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
  4 reports
• Affinity™ CP BBAP40

  Pump, blood, cardiopulmonary bypass, non-roller type
  4 reports
• Affinity™ CP AP40

  PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
  1 report
• Affinity™ CP CBAP40

  PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
  1 report
• Affinity™ CP CBAP40

  Pump, blood, cardiopulmonary bypass, non-roller type
  1 report

Recent Affinity CP adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionDec 4, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AFFINITY CENTRIFUGAL BLOOD PUMP, IT WAS REPORTED THAT A LARGE LEAK WAS NOTICED AT THE TOP OF THE CENTRIFUGAL PUMP. THE DEVICE WAS REPLACED. IT WAS UNKNOWN IF THERE WAS ANY ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS DAMAGE OR A CRACK NOTICED ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714292 ↗
• MalfunctionDec 4, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AFFINITY CENTRIFUGAL BLOOD PUMP, IT WAS REPORTED THAT WHILE PRIMING, A LARGE LEAK WAS NOTICED AT THE TOP OF THE CENTRIFUGAL PUMP. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS DAMAGE/CRACKS NOTICED ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714045 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO USE OF THE AP40 CENTRIFUGAL PUMP, PREPARING FOR AN EMERGENCY EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PROCEDURE IN THE INTERVENTIONAL CATHETERIZATION ROOM. WHILE CONNECTING THE CENTRIFUGAL PUMP HEAD TO THE CIRCULATION TUBING, THE CENTRIFUGAL PUMP HEAD BROKE. A NEW PUMP HEAD WAS IMMEDIATELY USED INSTEAD TO CONTINUE THE OPERATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED PHOTO OF THE DEFECTIVE PUMP HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802695 ↗
• MalfunctionMar 6, 2025Break; Material Puncture/Hole; Noise, Audible; Break; Material Puncture/Hole; Noise, Audible

  IT WAS REPORTED THAT DURING USE OF AN AFFINITY CENTRIFUGAL PUMP THE PUMP TIP HAD AN ABNORMAL SOUND AFTER THE PUMP WAS PUT ON 6 DAYS. IT WAS SUSPECTED THAT THE CERAMIC SHAFT OF THE PUMP TIP WAS BROKEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21534018 ↗
• MalfunctionFeb 20, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AP40 AFFINITY CENTRIFUGAL PUMP, IT WAS REPORTED THAT THE CONNECTION BETWEEN THE PUMP HEAD AND THE MOTOR BROKE. SEE ATTACHED PHOTOS. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21419429 ↗
• DeathNov 12, 2024Crack; Fluid/Blood Leak; Material Puncture/Hole; Air/Gas in Device; Crack; Fluid/Blood Leak; Material Puncture/Hole; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AP40 CENTRIFUGAL PUMP, IT WAS REPORTED THAT DURING THE ECMO PROCESS, A CRACK WAS NOTED ON THE DEVICE BY THE CUSTOMER. THE ECMO PIPELINE SYSTEM WAS IMMEDIATELY CHECKED AND THEY FOUND THAT AIR HAD ENTERED THE SYSTEM AND A BLOOD LEAK WAS ALSO OBSERVED. THE PATIENT BLOOD PRESSURE SUDDENLY DROPPED AFTER 3 HOURS OF BEING ON THE ECMO MACHINE. THE ECMO SYSTEM WAS URGENTLY REPLACED, BUT THE PATIENT DIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 20663717 ↗
• MalfunctionSep 10, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN AFFINITY CENTRIFUGAL PUMP, IT WAS REPORTED THAT THE TIP OF THE PUMP WAS CRACK ED. AFTER OPENING THE PACKAGE AND CONNECTING THE TUBE, THE CUSTOMER OBSERVED THAT THE BLOOD INLET OF THE DEVICE WAS BROKEN WHEN PREPARING FOR PRE-FILLING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179028 ↗
• DeathAug 14, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AP40 CENTRIFUGAL PUMP, IT WAS REPORTED THAT IN THE INTENSIVE CARE UNIT, THE PUMP HEAD/ FAN BLADE HIT THE WALL AND MELTED THE BLOOD. THE PATIENT IS DECEASED. THE CUSTOMER STATED THAT THE CAUSE OF PATIENT DEATH WAS HEMOLYSIS DURING THE DEVICE ISSUE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PUMP WAS IN USE FOR 20 MINUTES WHEN THE ISSUE OCCURRED AND IT DID NOT EXCEED THIS TIME. THE ANTICOAGULANT USED WAS HEPARIN.

  Patient problems: Hemolysis

  MAUDE report 19979991 ↗
• DeathAug 14, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AP40 CENTRIFUGAL PUMP, IT WAS REPORTED THAT THE PUMP TIP FAN BLADE HIT THE WALL. THE PATIENT IS DECEASED. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS RELATED TO THE ICU PROCEDURE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PUMP IN USE WHEN THE ISSUE OCCURRED DID NOT EXCEEDED 20 MINUTES. HEPARIN ANTICOAGULATION WAS USED.

  Patient problems: Hemolysis; Thrombosis/Thrombus

  MAUDE report 19979972 ↗
• MalfunctionFeb 2, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AFFINITY CENTRIFUGAL PUMP , IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A PUMP FAILURE. THE CENTRIFUGAL PUMP WAS RUNNING FINE UNTIL MOMENTS AFTER GIVING CARDIOPLEGIA. THE PUMP WAS AT 3000 RPMS WITH CI OF <(><<)>= 1.0, WHICH SHOULD NOT HAPPEN AT THAT RPM. THE CUSTOMER CHANGED IT OUT TO ANOTHER MANUFACTURER'S PUMP AND THINGS WERE FINE AFTER THAT. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED LOW FLOW PERFUSION SINCE CUSTOMER WAS UNABLE TO INCREASE CENTRIFUGAL PUMP FLOW. CARDIAC INDEX WAS <(><<)>= 1.0 WITH HIGH RPMS.THE CUSTOMER REPORTED THAT THE LONG TERM EFFECT WAS UNKNOWN AT THIS TIME SINCE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PUMP WAS USED IN AN AP40AST. THE CIRCUIT WAS REVIEWED AND THERE WERE NO CLAMPED LINES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630322 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 23, 2023Crack; Fluid/Blood Leak; Air/Gas in Device; Crack; Fluid/Blood Leak; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AP40 CENTRIFUGAL PUMP, IT WAS REPORTED THAT THERE WAS BLOOD LEAKAGE FROM THE CENTRIFUGAL PUMP THAT AFFECTED THE NORMAL USE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS AIR IN THE SYSTEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16982346 ↗

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