AMG PMP INFANT STERILERecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08052705493368), received between Dec 11, 2024 and Aug 12, 2026 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (12 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50228930 ↗
• MalfunctionAug 10, 2026Fluid/Blood Leak

  It was reported that there were issues with two Oxygenators leaking from the purge line. The extracorporeal membrane oxygenation (ECMO) circuits were kept primed and ready for Extracorporeal Cardiopulmonary Resuscitation (eCPR), and during the routine checks it was noticed that there was moisture around the purge line coming off the top of the Oxygenators. It was attempted to tighten the connection, but it continued to leak which led to the two Oxygenators needing to be replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194922 ↗
• MalfunctionAug 10, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194910 ↗
• InjuryMay 18, 2026Improper Chemical Reaction

  IT WAS REPORTED THAT ON (B)(6) 2026, ABOUT AN HOUR AFTER A NEW PATIENT WAS INITIATED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) USING AN OXYGENATOR, THE POST-MEMBRANE PO2 WAS ONLY IN THE 70S AND THE PATIENT CONTINUED TO BE HYPOXIC. THE OXYGENATOR WAS CHANGED OUT AND THE PATIENT'S SYMPTOMS IMPROVED.

  Patient problems: Hypoxia

  MAUDE report 25209353 ↗
• MalfunctionApr 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE OXYGENATOR CONTAINED BLOOD IN THE LOWER ORANGE CHAMBER AND HAD BEEN CONNECTED TO A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867293 ↗
• MalfunctionApr 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE OXYGENATOR CONTAINED WATER IN THE LOW ORANGE CHAMBER AS WELL AS POOLED WATER IN THE SPACE ABOVE THE OXYGENATOR AND HEAT EXCHANGER. THE UNIT HAD ONLY BEEN WET PRIMED AND WAS NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839848 ↗
• MalfunctionMar 30, 2026Fracture

  IT WAS REPORTED THAT WHILE THE PERFUSION MACHINES WERE BEING PRIMED, THERE WAS A LEAK FROM THE LEUR PORT ASSOCIATED WITH THE ARTERIAL PRESSURE MONITORING LINE. AFTER INSPECTION, A CRACK WAS IDENTIFIED AT THE JUNCTION BETWEEN THE LEUR PORT AND THE BLOOD OUTLET PORT. THERE WERE NO ALARMS PRESENT AND THE OXYGENATOR WAS EXCHANGED IMMEDIATELY AND DISCARDED DUE TO CONTAMINATION. PUMP SPEED WAS APPROXIMATELY 2500 RPM AND FLOW WAS APPROXIMATELY 200 CC PER MINUTE. PRESSURE AT INLET AND OUTLET OF THE OXYGENATOR WAS NOT MEASURED. THE NEW OXYGENATOR WORKED VERY WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717377 ↗
• MalfunctionJan 29, 2026Fracture; Mechanical Problem

  IT WAS REPORTED THAT DURING A PRIMING A NEWBORN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SET THE PERFUSIONIST NOTICED A LEAKAGE IN ARTERIAL CONNECTOR OF ECMO OXYGENATOR. THERE WAS A VISIBLE CRACK OR SCRATCH IN THE CONNECTOR FROM WHICH THE LEAK WAS COMING. THE ECMO SET WAS NOT USED, BUT THE PERFUSIONIST USED A NEW SET INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24217855 ↗
• MalfunctionJan 26, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PURGE LINE APPEARED TO BE CRACKED AT THE TOP OF THE AMG INFANT OXYGENATOR AT THE PORT CONNECTING THE TUBING. THIS WAS NOTICED DURING SETUP, THEREFORE NEVER USED AND NO INTERACTION WITH THE PATIENT. THE OXYGENATOR WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183665 ↗
• MalfunctionJan 16, 2026Mechanical Problem

  IT WAS REPORTED THAT WHEN BUILDING A NEW CIRCUIT AND CONNECTING ONE OF THE PRESSURE TRANSDUCER LINES TO THE LUER CONNECTION NEAR THE BLOOD INLET PORT, THE LUER CAP BROKE OFF INSIDE THE CONNECTION. THE OXYGENATOR WAS CUT OUT AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094947 ↗
• MalfunctionDec 18, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS ADDITIONALLY REPORTED THAT THERE WAS NO PATIENT DIRECTLY INVOLVED. THE ISSUE WAS FOUND PRIOR TO BEING PUT ON THE PATIENT. THIS WAS A NEW BACKUP CIRCUIT AND 200 UNITS OF HEPARIN INFUSED DURING BLOOD PRIME. THE OXYGENATOR HAD BEEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844959 ↗
• MalfunctionNov 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS ADDITIONALLY REPORTED THROUGH MW5178980 THAT THE OXYGENATOR LEAKED FLUID FROM THE OXYGENATOR MODULE. THIS WAS OBSERVED WHILE PRIMING PRIOR TO INITIATING SUPPORT AND WAS PROMPTLY CHANGED BEFORE THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE OXYGENATOR WAS NEVER USED ON A CIRCUIT ATTACHED TO A PATIENT. THE OXYGENATOR WAS NOT EXPOSED TO BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648701 ↗
• MalfunctionNov 24, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INFANT OXYGENATOR ARRIVED WITH THE INFLOW CONNECTION DAMAGED. THE ISSUE WAS FOUND UPON REMOVAL FROM BOX AND WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23634141 ↗
• MalfunctionNov 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED STATED THAT FOR THE FIRST OXYGENATOR THAT LEAKED FROM THE PURGE LINE CONNECTION, THE LEAK WAS NOTICED THE FOLLOWING DAY. FOR THE SECOND OXYGENATOR WITH A SLOW LEAK OF PRIMING FLUID (B)(6), THE LEAK WAS NOTICED RIGHT AFTER PRIMING WAS COMPLETED. THE SAME PRIMING TECHNIQUE WAS USED ON ALL THREE OXYGENATORS. FOR THE THIRD OXYGENATOR THAT WAS LEAKING, THE LEAK WAS NOTICED THE FOLLOWING DAY AFTER THE CIRCUIT WAS PRIMED. THE SOURCE OF THE LEAK WAS THE PURGE LINE CONNECTION POINT. THIS WAS THE SAME LOCATION FOR ALL THREE OXYGENATORS. THE PUMP SPEED FOR ALL THREE OXYGENATORS WAS 1500 RPMS WITH 1.5 LPM OF FLOW FOR ABOUT A COUPLE MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623739 ↗
• MalfunctionNov 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION RECEIVED STATED THAT FOR THE FIRST OXYGENATOR THAT LEAKED FROM THE PURGE LINE CONNECTION (B)(6), THE LEAK WAS NOTICED THE FOLLOWING DAY. FOR THE SECOND OXYGENATOR WITH A SLOW LEAK OF PRIMING FLUID, THE LEAK WAS NOTICED RIGHT AFTER PRIMING WAS COMPLETED. THE SAME PRIMING TECHNIQUE WAS USED ON ALL THREE OXYGENATORS. FOR THE THIRD OXYGENATOR THAT WAS LEAKING, THE LEAK WAS NOTICED THE FOLLOWING DAY AFTER THE CIRCUIT WAS PRIMED. THE SOURCE OF THE LEAK WAS THE PURGE LINE CONNECTION POINT. THIS WAS THE SAME LOCATION FOR ALL THREE OXYGENATORS. THE PUMP SPEED FOR ALL THREE OXYGENATORS WAS 1500 RPMS WITH 1.5 LPM OF FLOW FOR ABOUT A COUPLE MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622198 ↗
• MalfunctionNov 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE THIRD BRAND NEW NEONATE AMG PMP OXYGENATOR WAS SAID TO BE LEAKING FROM THE SAME PURGE LINE CONNECTION POINT. THE OXYGENATOR WAS EXCHANGED AGAIN WITH ANOTHER NEONATE AMG PMP OXYGENATOR THAT HAD A DIFFERENT MANUFACTURING DATE AND EXPIRATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622197 ↗
• MalfunctionJun 16, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE FULL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED AT 10:15AM WITH SETTINGS OF RPM 2120, QB 1.1 LPM, FIO2 70%, SWEEP 0.5 LPM. VENOUS BLOOD GAS (VBG) WAS DRAWN AT 10:26 WITH THE RESULTS: 6.83/82/57/13.5/-21/67%, FIO2 WAS INCREASED TO 100% AND SWEEP 1.0 LPM. POST MEMBRANE ARTERIAL BLOOD GAS (ABG) WAS DRAWN AT 10:33 WITH RESULTS: 7.05/>98/65/82.8%. THE GAS SOURCE WAS CHANGED TO O2 TANK AT 1.5 LPM, 2ND POST MEMBRANE ABG DRAWN AT 10:45 WITH RESULTS: 7.06/62/73/17.5/-13/88.7%. THE DOCTOR WAS INFORMED OF THE FAILING OXYGENATOR AND THE DECISION WAS MADE WITH THE INTENSIVE CARE UNIT (ICU) TEAM TO CHANGE IT OUT. THERE WAS A PRIMED BACK UP PEDIATRIC AMG CIRCUIT AVAILABLE AND THE OXYGENATOR FROM IT WAS USED TO DO AN ISOLATED OXYGENATOR CHANGE OUT. THE PATIENT WAS OFF SUPPORT FOR ABOUT 1 MINUTE. THE ECMO WAS REINITIATED WITH THE SETTINGS OF RPM 2120, QB 1.1 LPM, FIO2 100%, SWEEP 1.5 LPM. POST MEMBRANE ABG WAS DRAWN 10 MINUTES AFTER CHANGEOUT, WITH RESULTS: 7.11/51/>500/16.4/-13/100%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215158 ↗
• MalfunctionMay 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE INFANT AMG OXYGENATOR WAS NOTED TO BE LEAKING PRIMING FLUID AT THE TOP OF THE OXYGENATOR. IT WAS ON A PRIMED CIRCUIT, NOT ON A PATIENT, SO IT WAS EXCHANGED FOR A NEW ONE. THE CIRCUIT WAS NOTICED TO BE LEAKING A FEW DAYS AFTER IT WAS PRIMED. THE PUMP WAS NOT RUNNING AT THE TIME AS THIS WAS PRIMED AS A BACKUP CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090779 ↗
• InjuryApr 10, 2025Fluid/Blood Leak; Insufficient Device Problem Information; Fluid/Blood Leak; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE OXYGENATOR FAILED AND WAS EXCHANGED.

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21816379 ↗
• InjuryMar 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT WAS ON VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) AND NOTED A BLOOD LEAK FROM THE PLASTIC RING COMING OFF THE PURGE LINE OF THE OXYGENATOR. THE LITTLE "BLACKBERRY" OBJECT WAS DRIED BLOOD AND WHEN REMOVED, THERE WAS BLOOD DRIPPING VERY SLOWLY FROM THAT AREA. THE PATIENT WAS POSITIVE FOR ENTEROVIRUS MENINGITIS. A CIRCUIT CHANGE WAS PERFORMED, AND THE PATIENT WAS GOOD AND OFF ECMO. CIRCUIT HAD BEEN CHANGED 2 DAYS PRIOR. THE PATIENT WAS ON 40% FROM THE ECMO CIRCUIT AND 0.85 L/MIN FLOW. THE WATER BATH WAS SET AT 39 AND THE BLOOD TEMPERATURE HAD BEEN 35.7 CONSISTENTLY THROUGHOUT THE RUN. THIS INCIDENT WAS NOTED ON (B)(6) 2025 AROUND 2100.

  Patient problems: Meningitis

  MAUDE report 21506209 ↗
• MalfunctionDec 30, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  PICTURES OF THE CRACKED OXYGENATOR WERE PROVIDED. THE PUMP SPEED, PRIMING FLUID FLOW AND INLET/OUTLET PRESSURES WERE UNABLE TO BE PROVIDED. THE DEVICE WOULD NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044493 ↗
• MalfunctionDec 11, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT UPON OPENING THE OXYGENATOR, THE CUSTOMER DISCOVERED THE ARTERIAL OUTFLOW CONNECTION WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20907507 ↗