Acrobat-i Positioner XP-5000Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00607567700574), received between Sep 10, 2020 and Mar 16, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Mechanical Problem

  THE HOSPITAL REPORTED THAT WHEN THE SURGEON ATTEMPTED TO SECURE THE ACROBAT-I STABILIZER DURING AN OPCAB PROCEDURE, FOLLOWING THE IFU INSTRUCTIONS, THE DEVICE FAILED TO LOCK. THE HARVESTER ATTEMPTED SEVERAL MORE TIMES, BUT THE SAME ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. THE PATIENT'S CONDITION WAS NORMAL. THERE WAS A 15-MINUTE DELAY. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603986 ↗
• MalfunctionFeb 4, 2026Mechanical Problem

  THE HOSPITAL REPORTED THAT THE ACROBAT-I POSITIONER HANDLE WOULD NOT TIGHTEN. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE CASE WITHOUT ISSUE. NO DEALY. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256544 ↗
• MalfunctionJun 11, 2025Suction Problem; Suction Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191203 ↗
• MalfunctionMay 20, 2025Positioning Problem; Positioning Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING ACROBAT-I POSITIONER, THE POSITIONER WOULD NOT LOCK IN PLACE EVEN WHEN I TURNED THE KNOB. THE ONLY TROUBLESHOOTING STEP TAKEN WAS RESOLVED BY USING A NEW DEVICE. THERE WAS NO SIGNIFICANT DELAY. THERE WAS NO SIGNIFICANT IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054606 ↗
• MalfunctionAug 29, 2023Suction Problem; Suction Problem

  THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I POSITIONER, THEY SAID THAT WHEN THEY WERE INSTALLING THE ACROBAT-I POSITIONER ON PLATFORM AND LOCK LEVER LOCKER IS AT LOCK POSITION BUT IS NOT WORKING FUNCTIONAL. THE ANGLE OF ACROBAT-I SWIVEL SHOULD PROVIDE 180 DEGREE SIDE-TO-SIDE RANGE OF MOTION OF THE ARM AND 90 DEGREE VERTICAL DROP AND SUCTION CUP SHOULD FIXED WHEN OPENING VACUUM PRESSURE BUT IN SOME OF ANGLE IT STUCK AND CAN NOT FIX FOR THE PARTICULAR ANGLE. SO THEY DECIDED TO REPLACE IT WITH A NEW ONE IMMEDIATELY WITHOUT USING ON THE PATIENT. THERE IS NO PROCEDURAL DELAY. THERE WAS NO HARM DUE TO THE POTENTIAL HARM PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644875 ↗
• MalfunctionNov 30, 2022Suction Failure; Suction Failure

  THE HOSPITAL REPORTED THAT A ACROBAT-I POSITIONER USED FOR A CORONARY ARTERY BYPASS PROCEDURE SUCTION CUP WAS STUCK AND CANNOT BE USED NORMALLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887707 ↗
• MalfunctionNov 1, 2022Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709309 ↗
• MalfunctionOct 20, 2022Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE ACROBAT-I POSITIONER WHEN TURNING THE KNOB PROPERLY TO FIX THE ARM, THE ARM WAS NOT FIXED. THIS REFERS TO THE FLEXLINX ARM BETWEEN THE SWIVEL AND THE SUCTION CUP. THE KNOB HAS BEEN TURNED ALL THE WAY TO ITS PEAK. THE OPERATION WAS SUCCESSFULLY COMPLETED USING THE NEW XP-5000Z. THERE WERE NO EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15643061 ↗
• MalfunctionJan 28, 2022Suction Failure; Suction Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I POSITIONER SUCTION CUP WAS NOT WORKING, WHILE THE SURGEON PLACED THE CUP ON THE APEX OF HEART. THEY CHECKED THE FUNCTION OF SUCTION END ON THE WALL, AND THAT'S NOT MALFUNCTION. AFTER THE SURGEON USED ANOTHER XP-5000, IT'S WORKING AND MADE THE OPERATION PROCEED. THE PATIENT WAS FINE, SINCE THE SURGEON CHANGED A NEW ONE WHILE FINDING IT'S NOT WORKING. THE SURGEON USED OM-10000 WITH XP-5000 TOGETHER IN THIS OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13387368 ↗
• MalfunctionOct 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I POSITIONER MALFUNCTIONED. PRODUCT WILL NOT BE RETURNING AS IT WAS DISPOSED

  Patient problems: Insufficient Information

  MAUDE report 12590541 ↗
• MalfunctionSep 1, 2021Packaging Problem; Packaging Problem

  GETINGE GROUP TAIWAN CO., LTD. REPORTED THAT DURING RECEIPT OF A SHIPMENT (ACROBAT-I POSITIONER), THEY RECEIVED THIS SHIPMENT AND THE OUTSIDE BOX WAS IN FINE CONDITION. BUT THEY FOUND ONE BOX WITH A HOLE AND CUSTOMER WON¿T ACCEPT THEM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12409592 ↗
• MalfunctionJun 22, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE HOSPITAL REPORTED THAT THEY ORDERED 5 KITS OF ACROBAT POSITIONERS AND 1 OF 5 WAS EXPIRED WHEN DELIVERED. KIT WAS OPENED BUT NOT USED IN CASE. STAFF RECOGNIZED DISCOLORED TUBING AND CHECKED DATE ON PACKAGING. KIT HAD BEEN EXPIRED FOR NEARLY A YEAR. SECOND KIT WAS OPENED AND THE CASE WAS COMPLETED WITHOUT ISSUE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046958 ↗
• MalfunctionMay 13, 2021Defective Component; Manufacturing, Packaging or Shipping Problem; Defective Component; Manufacturing, Packaging or Shipping Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819421 ↗
• MalfunctionSep 10, 2020Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDUREACROBAT-I POSITIONER NOZZLE WAS IDLING AND THEY COULD NOT FIX IT. AFTER SEVERAL TRIALS, IT WAS NOT FIXED IN THE SAME WAY, AND FINALLY A SUBSTITUTE WAS ISSUED AND THE CASE WAS SUCCESSFULLY COMPLETED. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515317 ↗