Acrobat SUV Stabilizer OM-9000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607567700543), received between Nov 20, 2020 and Apr 14, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 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-2272-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2022Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT SUV STABILIZER SYSTEM, THE QUALITY OF THE SUPPLENESS OF THE ARM HAS DETERIORATED. COMPARED TO THE DEMO PRODUCT THEY HAD, THE ARM CERTAINLY FEELS A LITTLE STIFF. THE PROBLEM WAS DISCOVERED DURING THE OPERATION . THEY FELT UNCOMFORTABLE WITH THE QUALITY OF THE OM-9000Z. THE CONTENT REPORTED IS THAT THE DEVICE IS ATTACHED TO THE BLADE. THE SURGERY HAS BEEN COMPLETED WITHOUT ANY PROBLEMS. ONLY THE TARGET PRODUCTS ARE USED. NO NEW DEVICES HAVE BEEN RELEASED. IT DID NOT AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14111286 ↗
• MalfunctionApr 27, 2021Positioning Failure; Positioning Failure

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731279 ↗
• MalfunctionNov 20, 2020Positioning Failure; Positioning Failure

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, USING ACROBAT-I STABILIZER. THEY DID THE POSITIONING AND TURNED THE NOZZLE TO FIX IT, IT SLIPPED AND COULD NOT BE FIXED. EVEN AFTER TRYING SEVERAL TIMES, 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 10879265 ↗