Acrobat-I Stabilizer OM-10000Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00607567700581), received between Jul 28, 2020 and Sep 30, 2026 — classified as 1 death, 50 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (20 reports).

1 FDA recall record name this device's identifier, 1 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. Jun 28, 2023Class IIOpen, Classified

   The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

   Z-2274-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952874 ↗
• MalfunctionSep 23, 2026Mechanical Problem

  The hospital reported that during MIDCAB Acrobat-i Stabilizer locking knob was not turning on first use so it was immediately replaced. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865373 ↗
• MalfunctionAug 13, 2026Break; Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232782 ↗
• MalfunctionAug 5, 2026Mechanical Problem

  n/a

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50138017 ↗
• MalfunctionMar 16, 2026Positioning Failure

  THE HOSPITAL REPORTED THAT DURING THE PROCEDURE, THE ACROBAT-I STABILIZER SYSTEM LOCKING LEVER WAS NOT WORKING. IT KEPT ROTATING AND COULD NOT BE TIGHTENED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WAS NO HARM OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24604462 ↗
• MalfunctionDec 23, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING THE OPCAB PROCEDURE, THE ACROBAT-I STABILIZER WAS UNABLE TO LOCK INTO POSITION ON THE UA-5001 BLADE. WHEN ATTEMPTING TO TIGHTEN THE STABILIZER ARM, THE TIGHTENING KNOB CONTINUED TO SPIN FREELY. UPON REMOVING THE STABILIZER, IT WAS DISCOVERED THAT A PIECE OF PLASTIC HAD DETACHED. THE PLASTIC PIECE AND STABILIZER ARM WERE REMOVED, AND A NEW STABILIZER ARM WAS OPENED AND THE PROCEDURE WAS COMPLETED. THE PIECE WAS LOCATED OUTSIDE THE BODY, ON TOP OF DRAPED TOWELS ALONG SIDE THE PATIENT AND CHEST AND RETRACTOR BLADES, ADJACENT TO THE SURGEON. THE PIECE WAS REMOVED BY THE SURGEONS HAND, TO THE SCRUB TECHS HAND AND THEN ONTO THE BACK TABLE. NO INJURY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875688 ↗
• MalfunctionDec 22, 2025Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 23873982 ↗
• MalfunctionDec 3, 2025Suction Problem; Insufficient Device Problem Information; Suction Problem; Insufficient Device Problem Information

  THE HOSPITAL REPORTED THAT THE SUCTION FUNCTION OF THE ACROBAT-I STABILIZER WAS NOT WORKING. THE AFFECTED DEVICE WAS REINSTALLED AND TESTED MULTIPLE TIMES; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE MALFUNCTION OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, RESULTING IN A SMALL DELAY. NO HARM TO THE PATIENT WAS REPORTED.

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

  MAUDE report 23703961 ↗
• MalfunctionDec 1, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT BEFORE THE PROCEDURE, ACROBAT-I STABILIZER WAS BROKEN, IT WOULD NOT LATCH, WHEN IT WAS OPENED. THE DEVICE WOULD NOT LOCK DOWN ON THE RETRACTOR. ANOTHER STABILIZER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677779 ↗
• MalfunctionNov 25, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT THE PATIENT WAS IN THE OR WHEN THE DEFECT WAS NOTICED. UPON OPENING THE ACROBAT-I STABILIZER, THE LOCKING MECHANISM WAS SPRUNG. ANOTHER DEVICE WAS PULLED AND THE PROCEDURE WAS COMPLETED WITHOUT INJURY. THERE WAS NO PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645639 ↗
• MalfunctionNov 21, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING AN OPCAB PROCEDURE, THE ACROBAT-I STABILIZER WAS ATTACHED TO THE RETRACTOR. WHEN THEY TRIED TO TIGHTEN THE DEVICE, THE TIGHTENING KNOB JUST KEPT SPINNING AND WOULD NOT TIGHTEN.

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

  MAUDE report 23622506 ↗
• MalfunctionJul 29, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED WHEN THE ADJUSTMENT KNOB WAS TURNED TO ITS FULLY TIGHTENED POSITION, THE ARM WAS EXPECTED TO BE SECURELY FIXED; HOWEVER, IT REMAINED LOOSE AND FAILED TO STABILIZE AS INTENDED. THE MEDICAL STAFF REPORTED THIS MALFUNCTION DURING SETUP. A NEW SET WAS IMMEDIATELY USED TO REPLACE THE DEFECTIVE ONE, AND THE SURGERY PROCEEDED WITHOUT ANY DELAY. THE ISSUE DID NOT AFFECT THE OPERATION, AND THE PATIENT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645618 ↗
• MalfunctionJul 2, 2025Break; Break

  THE HOSPITAL REPORTED THAT BEFORE THE PROCEDURE IN THE OR, THE ACROBAT-I STABILIZER ARM BROKE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SLIGHT DELAY IN THE PROCEDURE. THERE WERE NO PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387490 ↗
• MalfunctionMay 7, 2025Break; Break

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING ACROBAT-I STABILIZER, AS THE DEVICE WAS BEING TIGHTENED USING THE KNOB, A METAL PIECE "POPPED" OFF. THE PIECE WAS RETRIEVED AND SAVED ALONG WITH THE DEVICE FOR RETURN. THE DEVICE WAS STILL USED TO COMPLETE PROCEDURE. THERE WAS NO PROCEDURAL DELAY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981849 ↗
• MalfunctionFeb 19, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING THE PROCEDURE, THE ACROBAT-I STABILIZER LOCKING MECHANISM WOULD NOT WORK TO STABILIZE THE DEVICE ONTO THE ACCESS RAIL (RETRACTOR). THERE WAS NO PATIENT HARM. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. MINIMAL DELAY WHILE OPENING A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21416158 ↗
• MalfunctionFeb 12, 2025Break; Break

  THE HOSPITAL REPORTED THAT DURING THE USE OF THE ACROBAT-I STABILIZER (OM-10000), THEY DISCOVERED THAT INTERNAL SCREWS HAD LOOSENED, CAUSING COMPONENTS TO FALL OFF AND MAKING IT IMPOSSIBLE TO SECURE THEM. THE ISSUE WAS RESOLVED BY REPLACING THE (OM-10000) WITH A NEW UNIT. NO HARM WAS CAUSED TO THE PATIENT, AND THE SURGERY PROCEEDED WITHOUT DELAY. PER THE PHOTO, IT SHOWS THAT THE INTERNAL PARTS HAD BECOME LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370603 ↗
• MalfunctionJan 8, 2025Mechanical Problem; Suction Failure; Mechanical Problem; Suction Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21107993 ↗
• MalfunctionOct 23, 2024Break; Break

  THE HOSPITAL REPORTED ACROBAT-I STABILIZER METAL PIECE FROM THE SPRING CONNECTOR THAT ATTACHES THE STABILIZER TO THE RETRACTOR FELL OUT ON THE DRAPES. THEY USED THE DEVICE AS IS. A SLIGHT FEW MINUTES' DELAY AS THEY LOOKED FOR THE LOOSE PIECE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514562 ↗
• MalfunctionAug 30, 2024Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED DURING A CORONARY ARTERY BYPASS PROCEDURE, THE ACROBAT-I STABILIZER WOULD NOT TIGHTEN AND WAS STIFF. THERE WAS A 5 MINUTE PROCEDURAL DELAY WHEN WE HAD TO RUN AND GET A NEW STABILIZER. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20107593 ↗
• MalfunctionApr 17, 2024Mechanical Problem; Positioning Problem; Mechanical Problem; Positioning Problem

  ON 28-MAR 2024, THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER CANTILEVER COULD NOT BE LOCKED. REPEATED ATTEMPTS WERE MADE, BUT THE CANTILEVER COULD NOT BE LOCKED AND FIXED. THEREFORE, A NEW CARDIAC STABILIZATION SYSTEM (ACROBAT-I STABILIZER) COULD BE LOCKED NORMALLY AFTER REPLACEMENT, AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125999 ↗
• MalfunctionMar 11, 2024Positioning Problem; Positioning Problem

  THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER COULD NOT BE USED DUE TO FAILURE TO STABILIZE IT. THEY DETECTED THIS FAILURE IN THE PRODUCT IN THE PREVIOUS STEP, BEFORE HAVING TO USE IT AND HAD TO RESORT TO ANOTHER UNIT THAT HE HAD AVAILABLE AT THAT TIME. THIS SITUATION DID NOT CAUSE ANY TYPE OF PROBLEM FOR THE PATIENT.

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

  MAUDE report 18875031 ↗
• MalfunctionJan 30, 2024Positioning Problem; Positioning Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER SURGEON WAS NOT ABLE TO TIGHTEN THE STABILIZER KNOB. IT KEPT ROTATING AND DIDN'T GET TIGHT. PROCEDURE COMPLETED WITH A NEW DEVICE. THERE WERE NO PROCEDURAL DELAYS AND PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608747 ↗
• MalfunctionJan 26, 2024Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER WOULDN'T STABILIZE AND WOULDN¿T HOLD ON RAIL TO STABILIZE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PROCEDURAL DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592211 ↗
• MalfunctionDec 8, 2023Positioning Problem; Positioning Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291840 ↗
• MalfunctionApr 21, 2023Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING ACROBAT-I STABILIZER, THEY HEARD A STRANGE SOUND WHILE ROTATING THE KNOB AND INSTALLING THE EQUIPMENT. FAILURE TO LOCK ONTO RETRACTOR ARM WAS NOT ABLE TO TIGHTEN IN FIXED POSITION EVEN ROTATED THE KNOB TO HEAR THE CLICK SOUND. AFTER THAT THE STABILIZER IS WORKING NOT FUNCTIONAL, THEY DECIDED TO REPLACE IT WITH A NEW ONE IMMEDIATELY. NO PROCEDURAL DELAY. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788885 ↗