CentriMag™ CMAEK00Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05415067036414), received between Jun 21, 2024 and Jun 25, 2026 — classified as 1 death, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 10, 2025Open, Classified

   Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.

   Z-1099-2026 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Contamination /Decontamination Problem; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE CUSTOMER REQUESTED A NEW UNIT FOR THEIR DAMAGED UNIT AS A REPLACEMENT. ADDITIONAL INFORMATION STATED THAT THE CLAMSHELL WITH THE STERILE LOOP ARRIVED OPEN. IT WAS DISCOVERED WHEN A PERFUSIONIST OPENED THE DISPOSABLE TO BUILD THE CIRCUIT. IT WAS NOT USED ON A PATIENT; THUS THERE WERE NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623417 ↗
• MalfunctionNov 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE ISSUE OCCURRED APPROXIMATELY 20 MINUTES AFTER EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) INITIATION. IT WAS NOTED BLOOD WAS SEEN DRIPPING FROM THE BOTTOM OF THE OXYGENATOR. NO ISSUES WERE NOTED DURING THE PRIMING OF THE OXYGENATOR PRIOR TO SUPPORT. THE PUMP SPEED WAS 3800 ROTATIONS PER MINUTE AT 3.5 LITERS PER MINUTE FLOW. THE ACTIVATED CLOTTING TIME (ACT) AT THE TIME OF INITIATION WAS GREATER THAN 400 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622501 ↗
• MalfunctionOct 31, 2025Product Quality Problem; Product Quality Problem

  IT WAS ADDITIONALLY REPORTED THAT BOTH POUCHES OF PIGTAILS WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439174 ↗
• MalfunctionOct 17, 2025Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS ADDITIONALLY REPORTED THAT THE ISSUE OCCURRED IMMEDIATELY AFTER THE INITIATION OF THE SUPPORT. THE PATIENT DID NOT HAVE ANY ADVERSE EFFECT. IT WAS UNKNOWN HOW THE OXYGENATOR BECOME CRACKED. THE CRACK WAS LOWER THIRD OF THE OXYGENATOR, BETWEEN THE HEATER/COOLER HOOK UPS. NO ISSUES WERE NOTED DURING PRIMING, WHICH WAS DONE PRIOR TO TREATMENT. NO PHOTOS OR VIDEOS WOULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23322591 ↗
• MalfunctionAug 24, 2025Fracture; Mechanical Problem; Fracture; Mechanical Problem

  IT WAS REPORTED THAT THE PRE-CONNECTED CENTRIMAG PACK WAS DEFECTIVE. THE TEAM WAS CANNULATING A PATIENT THAT WAS GOING ON CENTRIMAG SUPPORT. THE FIRST TUBING THEY PRIMED THROUGH LEAKED SIGNIFICANTLY THROUGH THE PIGTAIL ON THE AMG. THEY FOUND A CRACK ON THE CONNECTOR AND PRIMED A NEW CIRCUIT DUE TO CONCERNS FOR STERILITY. THE CIRCUIT NEVER MADE IT TO THE PATIENT AND WAS AVAILABLE FOR RETURN. THERE WAS NO DELAY TO PATIENT SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22881561 ↗
• MalfunctionJul 17, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT UPON OPENING THE PRECONNECTED PACK (PCP) THE PERFUSIONIST NOTICED A PIN HOLE SIZE OPENING IN THE MIDDLE OF THE PRIME BAG. FLUID DRIPPED OUT. AS SOON AS THE PRIME FLUID WAS ADDED IT STARTED DRIPPING OUT, THERE WERE NO FLOWS AT THE TIME AND THIS WAS NOT NOTICED UPON INITIAL INSPECTION OF OPENING THE PACK. THE PACK WAS OPENED, PRIMED, AND USED IMMEDIATELY. THE HOLE WAS PATCHED WITH BONE WAX AND USED IMMEDIATELY FOR SUPPORT WITH NO DELAYS AND NO ISSUES TO THE PATIENT. THE PACK WAS DISCARDED AFTERWARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538984 ↗
• DeathJun 6, 2025Improper or Incorrect Procedure or Method; Gas/Air Leak; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; Gas/Air Leak; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PRE-CONNECTED PACK HAD ENTRAPPED AIR DURING THE PRIMING PROCESS, SEEMINGLY CAUSING THE PUMP TO MALFUNCTION. THE PRE-CONNECTED PACK WAS BEING PREPPED BY LESS COMFORTABLE STAFF THAT SEEMED TO ENTRAP A FAIR AMOUNT OF AIR IN THE CIRCUIT CAUSING THE PUMP TO SHUT DOWN. THIS WAS NOT DEEMED A DEVICE FAILURE BY THE PRACTITIONERS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161651 ↗
• MalfunctionJun 3, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT WHILE PRIMING THE PRE-CONNECTED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) KIT, A LEAK AND HOLE WAS NOTED IN THE RESERVOIR BAG. THE PRIMING PROCEDURE WAS ABORTED AND THE PRE-CONNECTED PACK WAS PLACED TO THE SIDE. THE CIRCUIT WAS NOT USED TO SUPPORT A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136372 ↗
• MalfunctionMar 11, 2025Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT UPON OPENING A NEW PRE-CONNECTED PACK (PCP) TO PRIME PRIOR TO A CASE, PRIMING BAG WAS FOUND TO BE PUNCTURED AND OXYGENATOR HOUSING FOUND TO BE CRACKED. A NEW PCP WAS PRIMED FOR PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575729 ↗
• MalfunctionMar 5, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PRECONNECTED PACK (PCP) REQUIRED A CIRCUIT EXCHANGE WITHIN 48 HOURS OF INITIATING SUPPORT. IT WAS NOTED THAT THERE WAS A DROP IN PO2 FROM 380 TO 150, THE PO2 WAS RECHECKED AND REMAINED LOW AT 140. SAO2 ON ARTERIAL BLOOD GAS (ABG) WAS HIGH 90'S. THIS WAS THE SECOND CIRCUIT IN ~15 PCP'S THAT NEEDED TO BE EXCHANGED WITHIN THE FIRST 48 HOURS OF SUPPORT. THE CIRCUIT EXCHANGE TO A NEW PCP RESOLVED THE ISSUES AND THERE WERE NO FURTHER EXCHANGES NEEDED. THE CIRCUIT WAS THROWN AWAY AND NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528718 ↗
• MalfunctionMar 5, 2025Improper Chemical Reaction; Improper Chemical Reaction

  NO FURTHER INFORMATION WAS KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21527720 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Contamination /Decontamination Problem; Mechanical Problem; Contamination /Decontamination Problem

  THERE WAS NOT A DELAY IN PROCEDURE RELATED TO THIS EVENT AND IT WAS ABORTED FOR OTHER REASONS. THERE WAS NO ADVERSE PATIENT IMPACT AS THIS PROCEDURE WAS ABORTED. THE PRODUCT WOULD NOT BE RETURNED AS IT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459135 ↗
• MalfunctionFeb 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT IMMEDIATELY AFTER PRIMING OF A NEW PRE-CONNECTED PACK THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) COORDINATOR NOTED LEAKING OF THE PRIMING FLUID OUT OF THE BLUE GAS EXHAUST WHILE THE CENTRIMAG WAS NOT RUNNING. THE CIRCUIT WAS NOT ON A PATIENT AND THERE WAS NO DELAY IN CARE. THE CIRCUIT WAS REMOVED AND SET ASIDE. A NEW PRE-CONNECTED PACK WAS OPENED AND PRIMED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315534 ↗
• MalfunctionJan 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  NO PRODUCT WOULD BE RETURNED AS ALL THE BLOOD RESIDUE COULDN'T BE REMOVED FROM THE CIRCUIT. THE PRODUCT COULD POSSIBLY CONTAIN BIOLOGICAL RESIDUE OF WHO RISK GROUP 4 OR 3 SUCH AS AVIAN FLU, SARS-COV-2 ETC. THE PRODUCT COULD ALSO POSSIBLY CONTAIN BIOLOGICAL RESIDUE OF WHO RISK GROUP 1 OR 2 (NON-INFECTIOUS SUBSTANCE) LIKE ADENO-ASSOCIATED VIRUS (AAV) TYPES 1 THROUGH 4, CLAMYDIAE, E-COLI ETC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21245760 ↗
• MalfunctionJan 24, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WHILE SETTING UP CENTRIMAG PRE CONNECTED PACK, THE PLASTIC CLAMSHELL THAT WAS PASSED TO THE FIELD OPENED UP. THIS EXPOSED THE STERILE PORTION OF THE CIRCUIT. SUBSEQUENTLY THE PACK HAD TO BE SCRAPPED. NEW PACK WAS PUT IN USE. THE STERILE PACKAGING APPEARED INTACT OUT OF BOX HOWEVER THERE WAS ANOTHER CIRCUIT, BEING SET UP THAT WAS CHECKED, AND THE SHELL WAS LOOSELY CONNECTED LIKE IT DID NOT SNAP ALL THE WAY CLOSED. VELCRO WAS PUT AROUND IT AND IT WAS LAID FLAT, SO IT DID NOT OPEN UP. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232745 ↗
• MalfunctionJan 16, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WHILE SETTING UP THE CENTRIMAG PRE CONNECTED PACK, THE PLASTIC CLAMSHELL THAT WAS PASSED TO THE FIELD OPENED UP. THIS EXPOSED THE STERILE PORTION OF THE CIRCUIT. SUBSEQUENTLY THE PACK HAD TO BE SCRAPPED. A NEW PACK WAS PUT IN USE. THE STERILE PACKAGING APPEARED INTACT OUT OF BOX HOWEVER THERE WAS ANOTHER CIRCUIT BEING SET UP THAT WAS CHECKED, AND THE SHELL WAS LOOSELY CONNECTED LIKE IT DID NOT SNAP ALL THE CLOSED. VELCRO WAS PUT AROUND IT AND IT WAS LAID FLAT, SO IT DID NOT OPEN UP. THE CAUSE OF THE EVENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172391 ↗
• MalfunctionJan 15, 2025Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem; Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS SETTING UP CENTRIMAG PRE-CONNECTED PACK SERIAL NUMBER (B)(6) TO PRIME FOR USE AND THE PLASTIC CLAMSHELL THAT IS PASSED TO THE FIELD OPENED UP. THIS EXPOSED THE STERILE PORTION OF THE CIRCUIT. SUBSEQUENTLY THE PACK HAD TO BE SCRAPPED, AND ANOTHER PRE-CONNECTED PACK WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21161196 ↗
• MalfunctionNov 8, 2024Improper Chemical Reaction; Improper Chemical Reaction

  ADDITIONAL INFORMATION WAS RECEIVED THAT FOLLOWING STANDARD EVALUATION OF CIRCUIT GASES AND FOLLOW UP EVALUATION UTILIZING AN ALTERNATE TESTING MODALITY, THE AIR FLOW ACCESS FROM THE WALL TO THE BLENDER WAS VERIFIED AND IT WAS ENSURED THAT ALL ACCESS SITES WERE CONNECTED APPROPRIATELY. THE INTEGRITY OF THE GREEN GAS LINE/DISK CONNECTING THE BLENDER TO THE OXYGENATOR WAS CONFIRMED. EVENTUALLY, THE BLENDER WAS REMOVED ENTIRELY AND THE OXYGENATOR WAS CONNECTED TO A FULL TANK, WHICH DID NOT RESOLVE THE ISSUE. THE FIO2 WAS 1.0. THE PATIENT'S PARTIAL THROMBOPLASTIN TIME (PTT) WAS 87.8 AT THE TIME OF OXYGENATOR EXCHANGE. THEIR 24 HOUR RANGE WAS 87.8-155.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20643174 ↗
• MalfunctionOct 9, 2024Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING PRIMING FOR A PRE-CONNECTED PACK (PCP) FOR AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PATIENT, WHISTLING FROM THE OXYGENATOR WAS HEARD. THE OXYGENATOR WAS NOT USED AFTER PRIMING AS IT DID NOT SEEM CORRECT; THE PCP WAS NOT PLACED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20410444 ↗
• MalfunctionSep 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE OXYGENATOR WAS PRIMED AND WAS LEAKING FROM THE TOP; THERE WAS RAPID CONDENSATION AT THE TOP DRIPPING OUT OF THE BOTTOM OF THE OXYGENATOR. THERE WERE NO ALARMS. THE OXYGENATOR WAS CUT AWAY AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250761 ↗
• MalfunctionJun 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SPEED WAS AROUND 3000 RPM AND THE FLOW WAS AROUND 2.5 LPM. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) WAS AROUND THE 200S. THE SOURCE OF THE LEAK WAS ABLE TO BE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588820 ↗