Acrobat-I StabilizerRecalls & reported problems across all models

We found 2 models of Acrobat-I Stabilizer by Maquet Cardiovascular LLC in the FDA's device registry (GUDID). Together they are named in 171 adverse event reports in the FDA's MAUDE database, received between Jul 28, 2020 and Sep 30, 2026 — classified as 1 death, 1 injury, 169 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (69 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Acrobat-I Stabilizer recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 16, 2024Open, 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, 2023Open, 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 ↗

3. Jun 28, 2023Open, 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 Acrobat-I Stabilizer problems

Acrobat-I Stabilizer models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Acrobat-I Stabilizer OM-10000Z

  Stabilizer,Heart
  2 recalls120 reports
• Acrobat-I Stabilizer OM-10000

  Stabilizer,Heart
  1 recall1 death51 reports

Recent Acrobat-I Stabilizer adverse event reports

The 15 most recent reports across all models, 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 6, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50152612 ↗
• MalfunctionAug 5, 2026Mechanical Problem

  n/a

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50138017 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 21, 2026Detachment of Device or Device Component

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128554 ↗
• 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 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 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 ↗
• 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 ↗

Other Maquet Cardiovascular LLC products

• Vasoview Hemopro2 models · 646 reports · 6 recalls
• Acrobat-i Positioner2 models · 48 reports · 2 recalls
• Acrobat SUV Stabilizer2 models · 22 reports · 2 recalls