Z-0137-2024Class II

Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures...

Name: Z-0137-2024 Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures...
Creator: Maquet Cardiovascular, LLC
Published: 2023-09-13
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2023-09-13 / Open, Classified / root cause: design

FDA source

Maquet Cardiovascular, LLC began a recall of Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product... on 2023-09-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0137-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-13
Posted: 2023-10-22
Recalling firm: Maquet Cardiovascular LLC
Product: Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Product code: MWS Stabilizer, Heart
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Maquet /Getinge issued Urgent Device Medical Device Removal (FSCA 2242352-09/06/2023-004-R) via FedEx with delivery receipt on 9/13/23. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any of the Acrobat-i Stabilizer System with the product codes/lot numbers listed in this notice. If you have unused/unexpired affected product that you will be returning from your inventory, please contact Maquet/Getinge Customer Service at 888-880-2874 between the hours of 6 AM and 5 PM Pacific Standard Time to request a return authorization number (RMA) and shipping instructions. If you have affected product, you are entitled to a credit. You will receive credit upon your acknowledgement that you have affected product for return. Please complete and sign the attached MEDICAL DEVICE Removal - RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by emailing a scanned copy to [email protected] or by faxing the form to (877) 634-6230. Please forward this information to all current and potential Acrobat-i Stabilizer System users within your hospital / facility.
Quantity in commerce: 2951 units
Distribution: Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR
Product codes and lots: UDI-DI: 00607567100008 Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0137-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0137-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-22

Product code MWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)