Recall Z-0137-2024 ยท MWS Stabilizer, Heart
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
| Date | Oct 22, 2023 (initiated Sep 13, 2023) |
| Status | Open, Classified |
| 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 a |
| Quantity | 2951 units |
| Distribution | Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.