Terumo® Advanced Perfusion System 1 801763Recalls & reported problems

Summary

The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 00886799000656), received between May 21, 2018 and Sep 14, 2026 — classified as 1 death, 229 malfunctions.

The most frequently reported specific device problem is “Output Problem” (82 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 25 most recent of 230 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Charging Problem

  Patient problems: Insufficient Information

  MAUDE report 50765732 ↗
• MalfunctionMar 19, 2026Charging Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE HEART LUNG MACHINE (HLM) DISPLAYED A 'BATTERY CANNOT BE CHARGED. FULL BACK UP MAY NOT BE AVAILABLE' MESSAGE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642769 ↗
• MalfunctionFeb 10, 2026Break

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE INSULATION ON THE POWER CORD WAS FOUND TO BE BROKEN AND CONDUCTIVE WIRES WERE EXPOSED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304620 ↗
• MalfunctionDec 22, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE BLOOD PARAMETER MONITOR (BPM) WOULD NOT CONNECT, AND THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED A '?' MARK OVER THE BPM ICON. AS MITIGATION, THE INTERFACE MODULE CABLE WAS MOVED TO ANOTHER PORT ON THE NETWORK INTERFACE CARD (NIC) BOARD, WHICH RESOLVED THE ISSUE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871122 ↗
• MalfunctionDec 19, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ARTERIAL ROLLER PUMP WENT TO COAST WITHOUT ANY ALERT. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857836 ↗
• MalfunctionDec 19, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW SENSOR STOPPED WORKING. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857694 ↗
• MalfunctionDec 19, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT DURING SETUP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE BATTERY WAS NOT CHARGING AND THERE WAS A 'BATTERY MAY NOT BE CHARGED, FULL BACKUP MAY NOT BE AVAILABLE' MESSAGE DISPLAYED. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851073 ↗
• MalfunctionDec 8, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEART LUNG MACHINE (HLM) DID NOT BOOT UP. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751332 ↗
• MalfunctionNov 17, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB), THE HEART LUNG MACHINE (HLM) BATTERIES WERE CHARGING BUT THE LIGHT WAS RED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572300 ↗
• MalfunctionNov 17, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB), THE HEART LUNG MACHINE (HLM) THE BATTERIES WERE CHARGING BUT THE LIGHT WAS RED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568300 ↗
• MalfunctionOct 30, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT HEART LUNG MACHINE (HLM) DISPLAYED A 'NO BATTERY BACKUP' MESSAGE. THERE WERE NO REPORTED CONSEQUENCES TO THE PATIENT. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

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

  MAUDE report 23431077 ↗
• MalfunctionOct 30, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEART LUNG MACHINE (HLM) KEPT ALARMING. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430788 ↗
• MalfunctionOct 28, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE ROLLER PUMP OCCLUSION WAS NOT SETTING CORRECTLY. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS OVER 40 CUBIC CENTIMETERS (CC) OF BLOOD LOSS. THERE WAS NO DELAY, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23409427 ↗
• MalfunctionOct 16, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEART LUNG MACHINE (HLM) HAD A 'QUESTION MARK' OVER THE BATTERY ICON BUT THERE WERE NO AUDIBLE ALERTS. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311019 ↗
• MalfunctionSep 19, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE HEART LUNG MACHINE (HLM) DISPLAYED A 'BATTERY CANNOT BE CHARGED. FULL BACKUP MAY NOT BE AVAILABLE' MESSAGE. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096720 ↗
• MalfunctionSep 4, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED RED X'S ON THE MONITOR OVER THE ICONS OF THE PUMPS AND OTHER DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974166 ↗
• MalfunctionAug 28, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY; THE HEART LUNG MACHINE (HLM) BATTERIES WERE NOT HOLDING A CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912437 ↗
• MalfunctionAug 18, 2025Battery Problem; Battery Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE BATTERIES FAILED TO HOLD SUFFICIENT CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829446 ↗
• MalfunctionAug 5, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE HEART LUNG MACHINE (HLM) POWER CORD HAD A LOOSE PRONG THAT WHEN MANIPULATED WOULD SWITCH THE UNIT TO BATTERY POWER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22723677 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEART-LUNG MACHINE (HLM) POWER CORD HAD A BROKEN PRONG. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22633275 ↗
• MalfunctionMar 20, 2025Connection Problem; Power Problem; Connection Problem; Power Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE HEART LUNG MACHINE (HLM) HAD MULTIPLE ALARMS WITHOUT ANY MESSAGES, SHOWING A RED X ON THE PUMPS AND MODULES. THE ALARMS CLEARED INSTANTLY AND REPEATED AFTER SEVERAL MINUTES. THE UNIT WAS USED FOR THE REMAINDER OF THE CASE AS IS SINCE THE ERRORS WERE NOT CAUSING ANY ISSUES TO THE SYSTEM OVERALL. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652023 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, A LINE PIN ON THE HEART LUNG MACHINE (HLM) POWER CORD BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649617 ↗
• MalfunctionMar 19, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED RED X'S OVER THE SUCTION AND VENT PUMP ICONS. THE CCM WAS USED FOR THE REMAINDER OF THE CASE WITH THE ALARMS CONTINUING. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649606 ↗
• MalfunctionMar 19, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE HEART LUNG MACHINE (HLM) BASE LOST POWER, WENT ON BATTERY, THEN POWER WAS RESTORED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21647077 ↗
• MalfunctionMar 10, 2025Device Alarm System; Device Alarm System

  DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE HEART LUNG MACHINE (HLM) WAS ALARMING WITHOUT DISPLAYING THE CAUSE OF THE ALARM. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560578 ↗