FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular, LLC: Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
- Recall number
- Z-0137-2024
- 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
- Status
- Open, Classified
- Initiated
- 2023-09-13
- Posted
- 2023-10-22
- Terminated
- not on file
- Reason
- 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
- 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 acrobati-mountbreak2023.act@getinge.com 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
- 2951 units
- Distribution
- Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR
- Lot, serial or model codes
- UDI-DI: 00607567100008 Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MWS
- Firm FEI
- 2242352
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28