Acrobat-i Positioner XP-5000ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00607567500006), received between Jul 20, 2021 and Feb 10, 2025 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (16 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Oct 16, 2024Class IIOpen, Classified

   Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

   Z-0484-2025 · Root cause: Process change control · Recall details · FDA record ↗

2. Oct 31, 2023Class IIOpen, Classified

   The Positioner Arm may not tighten or lock during normal use.

   Z-0589-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Suction Failure; Suction Failure

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21351645 ↗
• MalfunctionDec 21, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 CAUTERY STOPPED WORKING WHILE CAUTERIZING A BRANCH. IT RESUMED AFTER 15-20 SECONDS, BUT THEN STOPPED WORKING AGAIN. IT'S LIKELY THE POLYFUSE FEATURE WAS IN EFFECT, BUT IT'S NOT KNOWN. ANOTHER KIT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR DELAY IN THE PROCEDURE - ASIDE FROM THE FEW MINUTES TO OPEN ANOTHER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376085 ↗
• MalfunctionDec 8, 2023Suction Failure; Suction Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290810 ↗
• MalfunctionMar 13, 2023Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT-I POSITIONER MALFUNCTIONED; DID NOT TIGHTEN. A SECOND UNIT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16529582 ↗
• MalfunctionJan 24, 2023Mechanical Problem; Mechanical Problem

  TRACKWISE ID (B)(6). THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE ACROBAT-I POSITIONER WOULDN'T LOCK INTO PLACE WHEN MOVING IT TO THE BACK OF THE HEART. THE MALFUNCTION HAPPENED TWICE IN THE SAME CASE. A NEW BOX WAS OPENED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16238030 ↗
• MalfunctionJan 24, 2023Mechanical Problem; Mechanical Problem

  RELATED TO 745360. THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE ACROBAT-I POSITIONER WOULDN'T LOCK INTO PLACE WHEN MOVING IT TO THE BACK OF THE HEART. THE MALFUNCTION HAPPENED TWICE IN THE SAME CASE. A NEW BOX WAS OPENED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237640 ↗
• MalfunctionNov 22, 2022Break; Positioning Failure; Break; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE ACROBAT-I POSITIONER CH KNOB BROKE AND WOULDN'T TIGHTEN. KNOB WOULDN¿T LOCK INTO PLACE. A NEW KIT OPENED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845836 ↗
• MalfunctionNov 7, 2022Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE ACROBAT-I POSITIONER CH ARM WOULD NOT TIGHTEN ALL THE WAY ENOUGH TO HOLD THE HEART UP. THEY OPENED UP ANOTHER ONE TO FINISH THE CASE WITH NO PATIENT AFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743126 ↗
• MalfunctionOct 20, 2022Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I POSITIONER KNOB DIDN'T ENGAGE AND SPUN MULTIPLE TIMES WITHOUT LOCKING IN. NO PATIENT AFFECTS AND THEY USED THE DEVICE TO FINISH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15642584 ↗
• MalfunctionOct 18, 2022Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I POSITIONER KNOB ISN'T LOCKING IN WHEN TURNING IT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621492 ↗
• MalfunctionSep 29, 2022Positioning Failure; Positioning Problem; Positioning Failure; Positioning Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, - USING ACROBAT-I POSITIONER. WHEN THE KNOB IS TURNED TO FIX THE HEART POSITIONER WHILE IT IS IN USE, THE KNOB CANNOT STOP TURNING. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508545 ↗
• MalfunctionSep 13, 2022Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I POSITIONER UNIVERSAL MOUNT FAILED TO ATTACH TO THE DISTRACTOR AND LOCK IN. AFTER MULTIPLE ATTEMPTS A SECOND KIT WAS OPENED AND THE CASE WAS COMPLETED WITHOUT ADDITIONAL COMPLICATIONS. NO PATIENT HARM WAS CAUSED, NO SIGNIFICANT DELAY IN CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15413346 ↗
• MalfunctionAug 11, 2022Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE ACROBAT-I POSITIONER WAS NOT ABLE TO TIGHTEN THE POSITION. THEY HAD TO OPEN ANOTHER ONE TO COMPLETE THE CASE. THE FAULTY UNIT WILL RETURN. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214943 ↗
• MalfunctionAug 4, 2022Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I POSITIONER PRESSURE WAS NOT APPLIED PROPERLY EVEN WHEN SUCTION WAS CONNECTED, SO THE CARDIAC POSITION WAS NOT FIXED. THE OPERATION WAS SUCCESSFULLY COMPLETED BY EXCHANGING THE PRODUCT. THERE WAS NO ABNORMALITY IN THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15170932 ↗
• MalfunctionJul 12, 2022Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THEY FIXED THE ACROBAT-I POSITIONER CH AND TRIED TO FIX IT AGAIN BY TURNING THE KNOB BECAUSE THE ARM SLIPPED DURING USE, THE KNOB SLIPPED. FINISH THE PROCEDURE USING THE SPARE XP-5000Z. NO HEALTH HAZARD TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988029 ↗
• MalfunctionJun 22, 2022Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ARM FIXING OF ACROBAT-I POSITIONER WAS A LITTLE LOOSE. THEY REPLACED IT WITH A NEW ONE, AND WAS ABLE TO FIX IT SAFELY AND CONTINUED OPE. THERE WAS NO DAMAGE TO THE PATIENT'S HEALTH DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14772829 ↗
• MalfunctionJun 21, 2022Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, WHEN THEY FIXED THE XP-5000Z ACROBAT-I POSITIONER CH AND TRIED TO FIX IT AGAIN BY TURNING THE KNOB BECAUSE THE ARM SLIPPED DURING USE, THE KNOB SLIPPED. THEY CHANGED THE POSITION OF THE ARM AND TURNED THE KNOB, AND IT WAS FIXED, SO THEY CONTINUED THE PROCEDURE. NO HEALTH HAZARD TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760204 ↗
• MalfunctionJun 17, 2022Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I POSITIONER CH HANDLE PART SLIPPED, SO THEY STOPPED USING IT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO HEALTH HAZARD TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734505 ↗
• MalfunctionJun 10, 2022Positioning Problem; Positioning Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE ACROBAT-I POSITIONER DIDN'T ENGAGE WHEN TURNING THE KNOB AND IT WAS IN THE CASE. IT DIDN'T CAUSE ANY EFFECTS OR ISSUES BUT THEY HAD TO STRAIGHTEN THE FLEXLINK ARM AND RE-POSITION FOR IT TO TIGHTEN. NO PATIENT EFFECTS AND THEY WERE ABLE TO COMPLETE THE CASE WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14660531 ↗
• MalfunctionJun 3, 2022Positioning Problem; Positioning Problem

  THE HOSPITAL REPORTED THAT DURING AN A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT-I POSITIONER ARM DIDN'T TIGHTEN WHEN TURNING THE KNOB. NO PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597428 ↗
• MalfunctionJun 3, 2022Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING ACROBAT-I POSITIONER. WHEN TIGHTENING THE KNOB IT DIDN'T TIGHTEN THE POSITIONER. THE DEVICE WAS ON THE ACTIVATOR DRIVE. IT CAUSED NO PATIENT HARM AND THEY OPENED A NEW DEVICE TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597421 ↗
• MalfunctionMay 10, 2022Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING ACROBAT-I POSITIONER CH. WHEN THEY TRIED TO FIX THE XP-5000Z, THE HANDLE PART SLIPPED, SO THEY STOPPED USING IT. THERE IS NO PROBLEM USING THE SPARE XP-5000Z. NO HEALTH HAZARD TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14346850 ↗
• MalfunctionApr 4, 2022Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING THE ACROBAT-I POSITIONER CH THEY TURNED THE KNOB PROPERLY TO FIX THE ARM, BUT THE ARM WASN'T FIXED. THE KNOB COULD NOT BE TIGHTENED NORMALLY. IT WAS NOT LOCKED AND REMAINED FREE. EVEN WHEN THEY TURNED THE KNOB ALL THE WAY, IT CAME LOOSE. THERE ARE NO PHOTOS OR VIDEOS. THE DEVICE WAS LOCKED TO THE BLADE. THEY HAVE NO OBSTACLES AT HAND. THE SURGERY WAS SUCCESSFULLY COMPLETED USING THE NEW XP5000Z. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994627 ↗
• MalfunctionMar 4, 2022Positioning Problem; Positioning Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING ACROBAT-I POSITIONER Z, EVEN IF THEY TURNED THE KNOB, THEY COULDN'T FIX IT JUST BY TURNING IT, SO THEY USED A NEW PRODUCT AND FINISHED THE OPERATION. WHEN IT OCCURRED, IT WAS FIXED TO THE BLADE. THE KNOB IS TURNING IN THE RIGHT DIRECTION. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13674027 ↗
• MalfunctionFeb 25, 2022Positioning Problem; Positioning Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING ACROBAT-I POSITIONER CH, THEY TURNED THE KNOB PROPERLY TO FIX THE XP5000Z ARM, BUT THE ARM WASN'T FIXED. THE KNOB WAS TIGHTENED NORMALLY AND PEAKED (CLICKED), BUT THE FIXATION MOVED LOOSELY COMPARED TO OTHER LOT PRODUCTS. THE SURGERY WAS SUCCESSFULLY COMPLETED USING THE NEW XP5000Z. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13598924 ↗