Acrobat V Stabilizer OM-9100SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00607567700536), received between May 28, 2021 and Jun 7, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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-2273-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2023Mechanical Problem; Mechanical Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081171 ↗
• MalfunctionApr 21, 2023Mechanical Problem; Mechanical Problem

  RELATED TO 797386. THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE USING ACROBAT V STABILIZER SYSTEM. CUSTOMER STATES THAT WHEN THEY ATTEMPTED TO PUT THE OM-9100S STANDARD BLADES ON THE ACTIVATOR DRIVE MECHANISM/RETRACTOR, ONE OF THE BLADES WOULD NOT LOCK ON AND IT SLIDE OFF THE RETRACTOR ROD. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791809 ↗
• MalfunctionApr 21, 2023Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791305 ↗
• MalfunctionFeb 13, 2023Break; Break

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT SUV STABILIZER SYSTEM STEEL CABLE DISINTEGRATED AND BROKE. THEY STATES THAT THEY WENT ONE CLICK PAST. IT WAS FEELING LOOSE WHEN IT SHOULD BE TIGHT, VICE-VERSA. IT REACHED THE FAILURE AFTER TIGHTENING. THE SAFETY CRIMP WAS NOT-PERPENDICULAR TO CABLE. THERE WAS NOT A STRUGGLE/DIFFICULTY TO TURN THE KNOB. THERE WERE NO VISUAL ABNORMALITIES WITH ANY OF THE PARTS IN THE ASSEMBLY.

  Patient problems: Insufficient Information

  MAUDE report 16363144 ↗
• MalfunctionFeb 9, 2023Break; Break

  THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, ACROBAT V STABILIZER SYSTEM INTERNAL STEEL CABLE SNAPPED. IT BROKE WHILE THEY WERE PREPPING FOR ANASTAMOSIS. THEY WERE TURNING THE KNOB WHICH IS SUPPOSED TO TORQUE LIMITED AND THE CABLE SNAPPED. THERE WAS A PROCEDURAL DELAY DURING PROCEDURE . CASE WAS COMPLETED USING A SECONDARY STABILIZER. NO REPORTED PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335233 ↗
• InjuryOct 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643622 ↗
• InjuryMay 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900416 ↗