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

FDA device recall Z-0137-2024 · posted 2023-10-22 · Open, Classified

Recall details

Recalling firm

Maquet Cardiovascular, LLC

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

MWS

Quantity affected

2951 units

Distribution

Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR

Date initiated

2023-09-13

Date posted

2023-10-22

Location

Wayne, NJ