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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet Getinge

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 Class 2 Device Recall Maquet Getingesee related information
Date Initiated by FirmSeptember 13, 2023
Date PostedOctober 22, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0137-2024
Recall Event ID 93085
Product Classification Stabilizer, heart - Product Code MWS
ProductMaquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Code Information UDI-DI: 00607567100008 Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442
FEI Number 2242352
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionMaquet /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 in Commerce2951 units
DistributionNationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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