Acrobat SUV Stabilizer OM-9000ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00607567900004), received between Nov 19, 2020 and Jan 7, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (5 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. 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-0485-2025 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Mechanical Problem

  THE HOSPITAL REPORTED THAT THE ACROBAT SUV VACUUM STABLIZER SYSTEM WAS USED DURING A CABG PROCEDURE. THE HANDLE WAS CLOSED, BUT THE ARM WAS LOOSE, SO THE DEVICE WAS DISCONTINUED AND REPLACED WITH A STABILIZER FROM ANOTHER MANUFACTURER, WHICH ALLOWED THE PROCEDURE TO PROCEED WITHOUT INCIDENT. THERE WAS NO DELAY. NO PATENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988787 ↗
• MalfunctionAug 13, 2025Positioning Problem; Positioning Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THEY TURNED THE ACROBAT SUV VACUUM STABILIZER SYSTEM KNOB BUT IT DID NOT LOCK IN PROPERLY. A NEW DEVICE WAS ISSUED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO MAJOR DELAY. NO HEALTH HAZARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796471 ↗
• MalfunctionJun 16, 2025Positioning Problem; Positioning Problem

  THE HOSPITAL REPORTED THAT DURING SURGERY USING ACROBAT SUV STABILIZER SYSTEM, EVEN WHEN THEY TURNED THE KNOB, THE ARM PART WAS NOT FIRMLY FIXED, SO THEY STOPPED USING IT. A DIFFERENT LOT OF PRODUCT WAS PREPARED AND USED, AND THE SURGERY WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO IMPACT OR DAMAGE TO THE PATIENT. THE CARDIOVASCULAR SURGEON WHO PERFORMED THE PROCEDURE IS WELL-VERSED IN THE PROCEDURE. THERE WERE NO PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212924 ↗
• MalfunctionFeb 13, 2025Suction Problem; Suction Problem

  THE HOSPITAL REPORTED THAT AFTER THE THORACOTOMY, THEY ATTEMPTED TO SECURE THE ACROBAT SUV VACUUM STABILIZER SYSTEM (OM-9000Z) FEET TO THE AFFECTED AREA, BUT THE SUCTION WAS TOO WEAK TO SECURE THE FEET, SO THEY UNPACKED A NEW KIT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO MAJOR DELAY. THERE WAS NO ADVERSE EFFECT ON THE PATIENT'S HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21377187 ↗
• MalfunctionNov 14, 2024Mechanical Problem; Suction Problem; Mechanical Problem; Suction Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE AFTER THE THORACOTOMY, ACROBAT SUV VACUUM STABILIZER SYSTEM, ST ARM WOULD NOT STAY IN PLACE NO MATTER HOW MUCH THE KNOB WAS TURNED. THE SUCTION WAS ALSO WEAK AND IT COULD NOT BE FIXED TO THE AREA. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO MAJOR DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20691212 ↗
• MalfunctionJan 9, 2024Positioning Problem; Insufficient Device Problem Information; Positioning Problem; Insufficient Device Problem Information

  THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, ACROBAT SUV VACUUM STABILIZER SYSTEM, ST THE FIXING PART OF THE ACROBATIC SUV OM-9000Z WAS LOOSE AND COULD NOT BE FIXED PROPERLY. THE KNOB WAS TURNED TO SECURE (CLOSE) THE PRODUCT, BUT IT WAS NOT SECURED PROPERLY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAYS. THERE WERE NO EFFECTS TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480259 ↗
• MalfunctionSep 26, 2023Positioning Failure; Mechanical Problem; Positioning Problem; Positioning Failure; Mechanical Problem; Positioning Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816451 ↗
• MalfunctionAug 29, 2023Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING ACROBAT SUV STABILIZER SYSTEM. THEY TURNED THE HANDLE TO FIX THE ARM OF OM9000Z, BUT THE HANDLE BECAME LOOSE AND THEY COULD NOT FIX IT. THEY TOOK OUT A NEW OM9000Z AND USED IT TO COMPLETE THE OPE. THERE WERE NO PARTICULAR EFFECTS ON THE PATIENT, SUCH AS DELAYS IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17645342 ↗
• MalfunctionAug 1, 2023Mechanical Problem; Suction Failure; Mechanical Problem; Suction Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17438904 ↗
• MalfunctionApr 27, 2023Positioning Failure; Positioning Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823837 ↗
• MalfunctionDec 7, 2022Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15933528 ↗
• MalfunctionDec 1, 2021Component Missing; Component Missing

  THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE USING ACROBAT-I STABILIZER. WHILST OPENING COMPONENTS IT WAS DISCOVERED ONE OF THEM WAS MISSING FROM THE BOX. THEY BELIEVE THE MISSING PART IS THE ACTUAL STABILIZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909653 ↗
• MalfunctionOct 11, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12610951 ↗
• MalfunctionOct 11, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12610883 ↗
• MalfunctionOct 11, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12610824 ↗
• MalfunctionOct 11, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12610678 ↗
• MalfunctionOct 11, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12610660 ↗
• MalfunctionSep 24, 2021Component Missing; Incomplete or Missing Packaging; Component Missing; Incomplete or Missing Packaging

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526408 ↗
• MalfunctionNov 19, 2020Positioning Failure; Suction Failure; Positioning Failure; Suction Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10869091 ↗