Affinity™ CP AP40 (UDI 00643169855205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169855205), received between Dec 15, 2021 and Dec 4, 2025 — classified as 3 deaths, 8 malfunctions.

The most frequently reported specific device problem is “Crack” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionDec 15, 2021Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS AP40 CENTRIFUGAL PUMP DURING AN EXTRA-CORPOREAL MEMBRANE OXYGENATION (EMCO) OPERATION, IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW RATE WAS SLOW, AND IT WAS FOUND THAT THE CENTRIFUGAL PUMP HEAD AXIS OF THE CENTRIFUGAL PUMP WAS OFFSET. THE PUMP HAD BEEN IN USE FOR 25 MINUTES WHEN THE ISSUE OCCURRED. AFTER REPLACING THE CENTRIFUGAL PUMP HEAD WITH A NEW CENTRIFUGAL PUMP, THE PATIENT'S BLOOD FLOW COULD REACH THE NORMAL FLOW RATE. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS ISSUE. ADDITIONAL INFORMATION: THE PERFUSION RECORDS PROVIDED FOR THE CASE WERE 85/47 MMHG, ROTATING SPEED 2080. THE PRIMING SOLUTION WAS COMPOSED OF NORMAL SALINE AND HEPARIN. NOREPINEPHRINE AND DOBUTAMINE WERE USED DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13008555 ↗