Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a s
Summary
The FDA issued a Class II for Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of by Maquet Cardiovascular, LLC. 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 o.
Details
Source
Device Recall
External ID
Z-0137-2024
Action Date
2023-11-01
Status
Ongoing
Category
device
Product Description
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
Lot/Code Info: UDI-DI: 00607567100008 Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442
Quantity Affected: 2951 units
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.
Distribution
Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-13
Company
Wayne, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Maquet Cardiovascular, LLC has 41 FDA actions in our database, including 37 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Maquet Cardiovascular, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Cardiovascular, LLC have FDA actions?
Maquet Cardiovascular, LLC has 41 FDA actions in our database, including 37 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0137-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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