Acrobat SUV StabilizerRecalls & reported problems across all models
Maquet Cardiovascular LLC · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Acrobat SUV Stabilizer model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 2 models of Acrobat SUV Stabilizer by Maquet Cardiovascular LLC in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Nov 19, 2020 and Jan 7, 2026 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (6 reports).
2 FDA recall records name at least one of these models by its device 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. 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
Reports received per month, all models
Acrobat SUV 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.
- 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-0485-2025 · Root cause: Process change control · Recall details · FDA record ↗
- 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-2272-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported Acrobat SUV Stabilizer problems
Device problems
- Mechanical Problem6
- Positioning Failure6
- Device Damaged Prior to Use5
- Positioning Problem4
- Component Missing2
- Suction Failure2
- Suction Problem2
- Incomplete or Missing Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Consequences Or Impact To Patient2
Acrobat SUV Stabilizer models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Acrobat SUV Stabilizer OM-9000ZStabilizer,Heart1 recall19 reports
- Acrobat SUV Stabilizer OM-9000SStabilizer,Heart1 recall3 reports
Recent Acrobat SUV Stabilizer adverse event reports
The 15 most recent reports across all models, 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
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
MalfunctionApr 27, 2023Positioning Failure; Positioning Failure
MalfunctionDec 7, 2022Mechanical Problem; Mechanical Problem
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 ↗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
MalfunctionOct 11, 2021Device Damaged Prior to Use; Device Damaged Prior to Use
Other Maquet Cardiovascular LLC products
All Maquet Cardiovascular LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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