EM-TEC PEDIATRIC FLOW PROBE FOR 2ND GEN CENTRIMAG PRIMARY CONSOLE 201-30107Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640135140115), received between Sep 15, 2022 and Mar 9, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Mechanical Problem

  IT WAS REPORTED THAT THE POWER BUTTON ON THE BACK OF THE CENTRIMAG CONSOLE WAS LOOSE. THIS WAS DISCOVERED DURING A REGULAR EQUIPMENT CHECK, AND THE DEVICE WAS TAKEN OUT OF SERVICE FOR EVALUATION. THE FLOW PROBE WAS RETURNED AND DETERMINED TO HAVE BEEN DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552679 ↗
• MalfunctionMar 15, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT, WHO WAS ON A PEDIMAG, HAD SUCTION EVENTS ON THE EVENING ON (B)(6) 2023. NO ALARMS WERE TRIGGERED. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED A LOW FLOW EVENT SHOWING A DROP TO 0 LITERS PER MINUTE (LPM), ASSOCIATED WITH A LOSS OF FLOW SIGNAL. THE EVENT WAS MUTED OR CLEARED WITHIN 5 SECONDS. THE FLOW DROPPED TO APPROXIMATELY 1.0 LPM (LOWEST VALUE RECORDED WAS 0.9 LPM.) THIS DID NOT RESULT IN AN ALARM BECAUSE THE ALARM THRESHOLD WAS SET TO 0.5 LPM AT THE TIME. THERE WAS ANOTHER LOW FLOW SHOWING 0 LPM, AGAIN ASSOCIATED WITH A LOSS OF FLOW SIGNAL. THIS ALARM WAS ALSO MUTED/CLEARED. AGAIN, THERE WAS ANOTHER LOW FLOW SHOWING 0 LPM, AGAIN ASSOCIATED WITH A LOSS OF FLOW SIGNAL, WHICH WAS ALSO MUTED/CLEARED. RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2024-00442, 3003306248-2024-00439, 3003306248-2024-00441

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915429 ↗
• InjuryFeb 16, 2024Infusion or Flow Problem; No Apparent Adverse Event; Infusion or Flow Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE SCREEN SHOWED NO FLOW. THE PATIENT WENT INTO ARREST AND ADVANCED RESUSCITATION MANEUVERS WERE INITIATED, AS WELL AS HIGH INOTROPIC SUPPORT. THEY PERFORMED AN EMERGENCY CHANGE; THEY WENT TO THE BACKUP MOTOR AND BACKUP CONSOLE. FLOW WAS REESTABLISHED AND THE PATIENT CAME OUT OF ARREST. IT WAS NOTED THAT THE PATIENT HAD BEEN ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT SINCE (B)(6) 2023 FOR TRACHEOESOPHAGEAL FISTULA/ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS). THE PATIENT WAS HEMODYNAMICALLY STABLE. RELATED MANUFACTURER REFERENCE NUMBER: 2916596-2024-00789 (CENTRIMAG CONSOLE). RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2024-00407 (CENTRIMAG MOTOR). RELATED MANUFACTURER REFERENCE NUMBER: 3003306248-2024-00408 (CENTRIMAG BLOOD PUMP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18725743 ↗
• MalfunctionSep 15, 2022Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) WITH EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE PATIENT PRESENTED HEMODYNAMIC DECOMPENSATION THAT REQUIRED INOTROPIC SUPPORT, THE PATIENT RECOVERED WITHOUT PROBLEM. THE PATIENT PRESENTED LOSS OF FLOWS ON THREE OCCASIONS. THE CONSOLE DID NOT REGISTER THE FLOW. THE DECISION WAS MADE TO CHANGE THE CONSOLE AND BACKUP FLOW PROBE AND THE FLOW WAS NORMALIZED. THE ENGINE WAS NOT CHANGED. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THE PATIENT WAS STABLE. MANUFACTURER REPORT NUMBER OF CONSOLE: 3003306248-2022-12509.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15434276 ↗