Acrobat-I Stabilizer OM-10000ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 00607567100008), received between Nov 13, 2020 and Aug 6, 2026 — classified as 1 injury, 119 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (49 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-0486-2025 · Root cause: Process change control · Recall details · FDA record ↗

2. Sep 13, 2023Class IIOpen, Classified

   Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.

   Z-0137-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50152612 ↗
• MalfunctionMar 19, 2026Component Missing

  THE HOSPITAL REPORTED THAT BEFORE THE PROCEDURE, THE ACROBAT-I STABILIZER Z STERILE TUBING IS MISSING FROM THE PACK, MAKING IT IMPOSSIBLE TO USE THE KIT BECAUSE THERE ARE NO SUCTION TUBES. A NEW DEVICE WAS USED TO COMPLETE THE CASE.

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

  MAUDE report 24636302 ↗
• MalfunctionJan 21, 2026Detachment of Device or Device Component

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128554 ↗
• MalfunctionDec 15, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING THE PROCEDURE, ACROBAT-I STABILIZER Z ROTATING KNOB MALFUNCTIONED. IT KEPT ROTATING AND COULDN'T BE TIGHTEN. THE SURGEON COMPLETED THE PROCEDURE WITH A NEW DEVICE. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM.

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

  MAUDE report 23801214 ↗
• MalfunctionDec 10, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING THE PROCEDURE THE ACROBAT-I STABILIZER DID NOT LOCK INTO PLACE EVEN AFTER TURNING THE KNOB, SO A NEW DEVICE WAS USED. NO HEALTH PROBLEMS WERE REPORTED TO THE PATIENT. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766977 ↗
• MalfunctionDec 1, 2025Component Missing; Component Missing

  THE HOSPITAL REPORTED THAT AFTER OPENING THE ACROBAT-I STABILIZER Z PACKAGING UNIT IT WAS DISCOVERED THAT THE STABILIZER WAS MISSING. THE PROBLEM OCCURRED BEFORE THE PROCEDURE, DURING THE SURGICAL PREPARATIONS. THE PATIENT WAS NOT IN THE OR. THERE WAS NO PROCEDURAL DELAY. THE VACUUM HOSE AND CONTAINER WERE INCLUDED. TO PERFORM THE PROCEDURE, ANOTHER PACKAGE HAD TO BE OPENED. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677778 ↗
• MalfunctionDec 1, 2025Mechanical Problem; Mechanical Problem

  N/A.

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

  MAUDE report 23677731 ↗
• MalfunctionDec 1, 2025Mechanical Problem; Mechanical Problem

  ASSOCIATED WITH TW: (B)(4). THE HOSPITAL REPORTED THAT DURING SURGERY 2 CONSECUTIVE STABILIZER SYSTEMS WERE USED WHERE THE HOLDING ARM COULD NOT BE LOCKED.

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

  MAUDE report 23677727 ↗
• MalfunctionNov 11, 2025Component Missing; Component Missing

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529117 ↗
• MalfunctionOct 20, 2025Break; Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335972 ↗
• MalfunctionOct 20, 2025Break; Break

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335971 ↗
• MalfunctionOct 15, 2025Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280751 ↗
• MalfunctionSep 22, 2025Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23115726 ↗
• MalfunctionSep 2, 2025Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932031 ↗
• MalfunctionAug 22, 2025Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER Z HANDLE WAS INOPERABLE AND WOULDN'T SECURE THE STABILIZER; IT KEPT ROTATING WITHOUT TIGHTENING. TO AVOID FURTHER DELAYS IN THE SURGERY, IT WAS REPLACED WITH ANOTHER ONE THAT WORKED CORRECTLY. NO INJURIES OR REQUIRED INTERVENTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22875057 ↗
• MalfunctionJul 15, 2025Break; Mechanical Problem; Break; Mechanical Problem

  THE HOSPITAL REPORTED DURING THE PROCEDURE, THAT THE ACROBAT-I STABILIZER HANDLE WOULD NOT TIGHTEN. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PROCEDURAL DELAYS. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22515780 ↗
• MalfunctionJul 9, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT-I STABILIZER TIGHTENING KNOB WAS DEFECTIVE. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF 5 MINUTES. THERE WERE NO EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459626 ↗
• MalfunctionJul 9, 2025Component Missing; Component Missing

  THE HOSPITAL REPORTED THAT PRIOR TO THE PROCEDURE, THEY OPENED AN OM-10000Z AND THERE WERE NO STANDARD BLADES IN THE BOX. THE STERILE BARRIER WAS REMOVED WHEN IT WAS NOTICED THAT THE BLADES WERE NOT IN THE PACKAGE. THIS WAS ALL NOTICED PRIOR TO THE PROCEDURE AND THEY OPENED ANOTHER BOX FOR THE PROCEDURE. THERE WAS NO PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458167 ↗
• MalfunctionJul 2, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING THE THIRD BYPASS, THE ACROBAT-I STABILIZER HANDLE DIDN'T WORK AND WOULDN'T LOCK THE STABILIZER IN PLACE; IT KEPT TURNING WITHOUT TIGHTENING. IT WAS REPLACED WITH ONE FROM THE SAME BATCH AND WORKED CORRECTLY. THERE WAS A DELAY AS IT INVOLVED CHECKING SEVERAL TIMES THAT IT DIDN'T WORK, UNTIL IT WAS DECIDED TO PERFORM ANOTHER ONE. THEREFORE, THIS DELAYS THE SURGERY. THERE IS NO INDICATION OF ANY INJURY TO THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387049 ↗
• MalfunctionJun 2, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT ACROBAT-I STABILIZER Z WAS UNSTEADY AND SHAKING INSPITE OF MAXIMUM TIGHTENING. COMPLETED THE PROCEDURE WITH THE NEW ONE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124013 ↗
• MalfunctionMar 14, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING ACROBAT-I STABILIZER Z (OM-10000Z), THE CASE COULD NOT PERFORM THE NECESSARY FLEXION MOVEMENT. IT BECAME STUCK EVEN THOUGH IT WAS USED FOR THE FIRST TIME DURING THE CASE. THE PROCEDURE WAS COMPLETED WITH THE SAME MATERIAL. THERE WAS A SLIGHT DELAY IN THE PROCEDURE. THE PATIENT WAS NOT HARMED DUE TO THE FAULTY DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612814 ↗
• MalfunctionMar 11, 2025Component Missing; Component Missing

  THE HOSPITAL REPORTED THAT WHILE PREPPING BACK TABLE FOR SURGERY, THEY OPENED ACROBAT-I VACUUM STABILIZER SYSTEM AND THE STABILIZER AND PART OF THE TUBING WERE MISSING FROM THE PACKAGE. THE PACKAGING WAS STERILE AND THERE WAS NO STABILIZER OR TUBING IN THERE.

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

  MAUDE report 21579872 ↗
• MalfunctionFeb 13, 2025Positioning Failure; Mechanical Problem; Positioning Failure; Mechanical Problem

  THE HOSPITAL REPORTED DURING THE PROCEDURE, THE ACROBAT-I STABILIZER Z ARM WAS LOOSE, A SPARE OM-10000Z WAS USED. THERE WAS NO PROCEDURAL DELAY. NO HEALTH HAZARDS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379295 ↗
• MalfunctionFeb 5, 2025Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE SURGEON WAS ABOUT TO START THE GRAFTING, HE FOUND THAT THE ACROBAT-I STABILIZER Z ROTATING KNOB WAS DEFECTIVE. IT KEPT ROTATING AND HE WAS NOT ABLE TO FIX IT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PROCEDURAL DELAY. THERE WERE NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318455 ↗
• MalfunctionJan 8, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED DURING THE PROCEDURE, THAT ACROBAT-I STABILIZER Z, EVEN AFTER TURNING THE KNOB, THE ARM WAS NOT FIRMLY FIXED, SO A DIFFERENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HEALTH RISK TO THE PATIENT. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21104274 ↗