Maquet Acrobat-i Vacuum Stabilizer System Intended for recall
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.…
Why was Maquet Acrobat-i Vacuum Stabilizer System Intended for recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00607567100008 Lot Numbers: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, 3000204442
- Product
- Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.…
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 2951 units
- Distribution
- Nationwide Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR
- Recall date
- November 1, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)