Terumo® Advanced Perfusion System 1 164267Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00886799000458), received between Jun 18, 2018 and Mar 19, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Break

  THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE CENTRIFUGAL DRIVE MOTOR HAD A BROKEN LATCH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642987 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT DURING TESTING OF THE DEVICE AT THE SERVICE CENTER, THE CENTRIFUGAL MOTOR WAS FOUND TO HAVE A BROKEN CLIP AND A LOOSE SPRING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23856366 ↗
• MalfunctionDec 16, 2025Break; Break

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE CENTRIFUGAL DRIVE MOTOR LATCH WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819216 ↗
• MalfunctionNov 4, 2025Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRAL CONTROL UNIT (CCU) WAS STUCK AT 700 REVOLUTIONS PER MINUTE (RPMS) WITHOUT ALARMING. THE TEAM WAS NOT ABLE TO SWITCH THE SPEEDS AND HAD TO SWITCH TO MANUAL DRIVE FOR THE REMAINDER OF THE CASE. 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 23472125 ↗
• MalfunctionMay 6, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE HEART LUNG MACHINE (HLM) HAD A BACK FLOW ALARM. THE PERFUSIONIST EXAMINED THE CENTRIFUGAL DRIVE MOTOR AND PUMP HEAD. IT WAS DETERMINED THAT THE PUMP HEAD HAD DECOUPLED FROM THE DRIVE MOTOR AND NEEDED TO BE RESEATED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A 10 SECOND DELAY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971343 ↗
• MalfunctionApr 17, 2025Output Problem; Output Problem

  DURING FIELD INSTALLATION OF THE DEVICE, THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT THE CENTRIFUGAL DRIVE MOTOR DISPLAYED A 'SERVICE PUMP' MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859909 ↗
• MalfunctionJul 9, 2024Break; Break

  AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE USER REPORTED THAT WHILE REMOVING THE DISPOSABLE TUBING THE CENTRIFUGAL DRIVE MOTOR SPRING CLIP BROKE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702662 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE WHITE CENTRIFUGAL DRIVE MOTOR CLIP BROKE. 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 18359995 ↗
• MalfunctionMar 7, 2023Decoupling; Noise, Audible; Decoupling; Noise, Audible

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRIFUGAL DRIVE MOTOR WAS NOISY. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A ONE-MINUTE DELAY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE USER REPORTED AN ISSUE WITH THEIR CENTRIFUGAL PUMP DRIVE MOTOR DURING CPB. SPECIFICALLY, THEY REPORTED A NOISY CENTRIFUGAL DRIVE MOTOR. THEY NOTED THAT THE NOISE WAS SLIGHTLY LOUDER WHEN COMPARED TO ANOTHER DRIVE MOTOR AT THEIR FACILITY. THE NOISE STARTED AFTER ATTACHING THE MEDTRONIC ADAPTER PLATE ON THE MANUFACTURER'S CENTRIFUGAL DRIVE MOTOR. THE MEDTRONIC ADAPTER PLATE WAS SUBSEQUENTLY ATTACHED TO A MEDTRONIC CENTRIFUGAL PUMP DISPOSABLE. THE USER DESCRIBED A LOUD SHUDDERING NOISE BUT STATED INITIALLY THAT THERE WAS NOT A LOSS OF PUMP FLOW. SUDDENLY, THEY NOTED A LOSS OF FLOW, WHICH THEY ATTRIBUTED TO A DECOUPLING OF THE CENTRIFUGAL PUMP TO THE DISPOSABLE AND ADAPTER PLATE. WHEN USING AN ADAPTER PLATE, THE DECOUPLING CAN BE BETWEEN THE ADAPTER PLATE AND THE DRIVE MOTOR, OR CENTRIFUGAL PUMP DISPOSABLE AND THE ADAPTER PLATE. TO MITIGATE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497558 ↗
• MalfunctionJan 23, 2023Infusion or Flow Problem; Output Problem; Infusion or Flow Problem; Output Problem

  IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE CENTRIFUGAL MOTOR FAILED TO PRODUCE FORWARD FLOW. THERE WAS A NOISE FROM THE MOTOR AND THEN A 'PUMP JAM' MESSAGE DISPLAYED ON THE CENTRIFUGAL CONTROL UNIT (CCU). 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 16224706 ↗
• MalfunctionAug 25, 2022Break; Break

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE CENTRIFUGAL DRIVE MOTOR CLIP THAT HOLDS THE ADAPTER WAS FOUND TO BE BROKEN. AS MITIGATION, THE USER USED A WIRE TO ENSURE THE CLIP WAS ENGAGED ONTO THE ADAPTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15299173 ↗
• MalfunctionMay 7, 2022Failure to Power Up; Output Problem; Failure to Power Up; Output Problem

  AFTER USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE , THE USER REPORTED THAT THE CENTRIFUGAL CONTROL UNIT (CCU) GAVE AN 'OVERSPEED' ALARM WHEN BARELY MOVING THE SPEED CONTROL KNOB, THEN IT WOULD NOT POWER UP AT ALL. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14315453 ↗
• MalfunctionMar 29, 2022Break; Break

  DURING THE RECEIVING PROCESS OF THE RETURNED DEVICE, THE CENTRIFUGAL DRIVE MOTOR WAS FOUND TO HAVE A BROKEN LATCH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13941748 ↗
• MalfunctionMar 26, 2022Break; Break

  IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE LATCH ON THE CENTRIFUGAL DRIVE MOTOR WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13918654 ↗
• MalfunctionMar 11, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS (CPB), THE CENTRIFUGAL DRIVE MOTOR HAD AN 'OVERSPEED' ALARM. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: ON (B)(6) 2022, THE TEAM EXPERIENCED A PROBLEM WITH THEIR HEART LUNG MACHINE (HLM) WHILE ON CPB, WHEREBY THE CENTRIFUGAL PUMP ALARMED 'OVERSPEED' AND STOPPED FUNCTIONING. THE UNIT WAS CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY, WITH NO DELAY AND NO BLOOD LOSS. THE PERFUSIONIST REPORTED HAVING TROUBLE MAINTAINING DESIRED FLOW ON THE CENTRIFUGAL CONTROL UNIT (CCU), EVENTUALLY REACHING MAXIMUM REVOLUTIONS PER MINUTE (RPMS). IT THEN ALARMED 'OVERSPEED' AND STOPPED. HE THEN HAND-CRANKED UNTIL THE CENTRIFUGAL HEAD COULD BE MOVED TO A MEDTRONIC 560 AND FINISHED THE CASE SUCCESSFULLY (THEY USED A MEDTRONIC CENTRIFUGAL HEAD WITH AN ADAPTOR ON THE MANUFACTURER MOTOR DRIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13732134 ↗
• MalfunctionMar 3, 2022Output Problem; Output Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) OF THE DEVICE, THE CENTRIFUGAL DRIVE MOTOR FAILED TESTING AND THE CENTRAL CONTROL MONITOR (CCM) DISPLAYED 'ARTERIAL: CONNECT MOTOR' AND 'ARTERIAL: OVERCURRENT' MESSAGES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13663812 ↗
• MalfunctionFeb 17, 2022Break; Break

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE CENTRIFUGAL DRIVE MOTOR WINDOW LATCH WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13553466 ↗
• MalfunctionFeb 11, 2022Break; Break

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE CENTRIFUGAL DRIVE MOTOR LATCH WAS FOUND BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13516046 ↗
• MalfunctionDec 20, 2021Output Problem; Output Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING FIELD SERVICE INSTALLATION OF THE DEVICE, AN OVERSPEED MESSAGE WAS OBSERVED ON THE PUMP DISPLAY AND THE MOTOR WOULD NOT ROTATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13046098 ↗
• MalfunctionApr 8, 2021Pumping Stopped; Output Problem; Pumping Stopped; Output Problem

  IT WAS REPORTED THAT DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE UNIT DISPLAYED A 'SERVICE PUMP' MESSAGE. THE PUMP WAS IN THE ARTERIAL POSITION AND STOPPED AND WOULD NOT RESTART. 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 11638339 ↗
• MalfunctionNov 25, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED STATED THAT AN ALTERNATIVE DEVICE WAS EMPLOYED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10900600 ↗
• MalfunctionJun 29, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEART LUNG MACHINE (HLM) HAD LOW FLOW GOING ON BYPASS WITH MAXED REVOLUTIONS PER MINUTE (RPMS). THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A 10 MINUTE DELAY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE PERFUSIONIST DISCUSSED WITH THE MANUFACTURER'S CLINICAL SPECIALIST ABOUT THE INCIDENT THE TEAM HAD WITH THEIR HLM DURING A CPB PROCEDURE ON (B)(6) 2020. THE TEAM SET UP THEIR MEDTRONIC DISPOSABLE AND MEDTRONIC PACK FOR PROCEDURES. THE TEAM USED THE MEDTRONIC APPROVED ADAPTER PLATE ATTACHED TO THE HLM DRIVE MOTOR. THE PACK CONSISTED OF THE MEDTRONIC BIOPUMP WHICH WAS USED FOR ALL PROCEDURES. THE PRACTICE OF PRIMING THE PUMP IS VARIED THROUGHOUT THE PRACTICE; SOME USERS DURING PRIME WOULD PLACE SOME PRESSURE ON THE ARTERIAL CIRCUIT TO MIMIC THE PATIENT PRESSURE, BUT SOME OTHERS DO NOT. THE USERS WHO DO CREATE A PRESSURE ON THEIR ARTERIAL CIRCUIT DURING PRIMING ONLY DO IT FOR A SMALL AMOUNT OF TIME TO TEST THEIR PRESSURE SYSTEM. THE PROTOCOL IS ADDITIONALLY VARIED FOR INITIATION OF BYPASS AND THEIR ACTIVATED CLOTTING TIME (ACT)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10210431 ↗
• MalfunctionJun 18, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE HEART LUNG MACHINE (HLM) WAS ONLY ABLE TO GET TWO LITERS PER MINUTE (L/MIN) OF FLOW EVEN THOUGH THE REVOLUTIONS PER MINUTE (RPM) WERE 3800. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THIS RESULTED IN A 10 MINUTE DELAY. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW: THE PERFUSIONIST DISCUSSED WITH THE MANUFACTURER'S CLINICAL SPECIALIST ABOUT THE INCIDENTS THE TEAM HAS HAD WITH THE HLM DURING A CPB PROCEDURE ON (B)(6) 2020. THE TEAM SETS UP THEIR MEDTRONIC DISPOSABLE AND MEDTRONIC PACK FOR PROCEDURES. THE TEAM USES THE MEDTRONIC APPROVED ADAPTER PLATE ATTACHED TO THE HLM DRIVE MOTOR. THE PACK CONSISTS OF THE MEDTRONIC BIOPUMP, WHICH IS USED FOR ALL PROCEDURES. THE PRACTICE OF PRIMING THE PUMP IS VARIED THROUGHOUT THE PRACTICE; SOME USERS DURING PRIME WOULD PLACE SOME PRESSURE ON THE ARTERIAL CIRCUIT TO MIMIC THE PATIENT PRESSURE, BUT SOME OTHERS DO NOT. THE USERS WHO DO CREATE A PRESSURE ON THEIR ARTERIAL CIRCUIT DURING PRIMING ONLY DO IT FOR A SMALL AMOUNT OF TIME TO TEST THEIR PRESSURE SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10171991 ↗
• MalfunctionMay 18, 2020Break; Break

  THE PRODUCT SURVEILLANCE TECHNICIAN (PST) REPORTED THAT DURING LABORATORY EVALUATION, THE CENTRIFUGAL DRIVE MOTOR HAD A DAMAGED LATCH ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10067417 ↗
• MalfunctionMar 23, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS (CPB) PROCEDURE, THE FLOW WAS LOW FOR THE GIVEN REVOLUTIONS PER MINUTE (RPMS) OF THE DEVICE. THE FLOW TO THE PATIENT WAS 2.3 LITERS PER MINUTE (LPM) WHILE THE RPMS WERE 3300. 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 Consequences Or Impact To Patient

  MAUDE report 9868390 ↗