Maquet Cardiovascular Recalls Cardiac Surgery Systems Due to Tyvek Pouch Defects
Maquet Cardiovascular is recalling specific cardiac surgery systems because internal findings identified pinholes or cuts in Tyvek pouches within the vacuum tubing sets.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect (pinholes/cuts) in a medical device used during cardiac surgery, which presents a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Acrobat V Vacuum Off-Pump System, Acrobat SUV Vacuum Off-Pump System, Axius Xpose 3 Access Device, and XPOSE 4 Access Device. These Class II medical devices are intended for use during cardiac surgical procedures through a sternotomy incision approach.
The recall was initiated after an internal finding identified the presence of pinholes or cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to the affected systems. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Approximately 16,532 units were distributed in the United States, with an additional 19,270 units distributed internationally. The affected products were distributed worldwide, including in the United States and numerous countries across the Americas, Europe, Asia, and the Middle East. Users should contact Maquet Cardiovascular for further instructions on how to proceed.
The recalled product
- Product
- Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of…
- Manufacturer
- Maquet Cardiovascular, LLC
Distribution
Distributed nationwide across the United States.
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