Maquet Acrobat-i Cardiac Stabilizer Jaw May Break During Surgery
The Maquet Acrobat-i Vacuum Stabilizer System's housing mount jaw may break during cardiac surgery, risking injury to heart tissue, blood vessels, or bypass grafts.
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: FDA Class II device with mechanical failure creating significant risk of injury to critical cardiac structures (heart tissue, blood vessels, coronary arteries, bypass grafts) during surgical use. No illnesses or injuries have been reported, placing this at Score 3 per the rubric for risk-of-harm products without reported injury.
Plain-English summary
The FDA is recalling the Maquet Acrobat-i Vacuum Stabilizer System, a surgical device used during cardiac procedures performed through a sternotomy incision (a cut through the breastbone). The recalled devices are identified by Product Code OM-10000Z and include approximately 2,951 units distributed nationwide and internationally.
The housing mount jaw component of the device may break during normal use. If the jaw breaks during surgery, it can potentially cause injury to the epicardial tissue (the membrane surrounding the heart), blood vessels, coronary arteries, or previously placed bypass grafts. A jaw failure could also result in procedural delay or the need to convert to an alternative surgical approach.
Healthcare facilities and cardiac surgeons using this device should stop use immediately and contact Maquet Cardiovascular, LLC for guidance. The affected lot numbers are: 3000188485, 3000193165, 3000193670, 3000195673, 3000198652, 3000199944, 3000201253, and 3000204442.
The recalled product
- Product
- Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z
- Manufacturer
- Maquet Cardiovascular, LLC
- Affected units
- 2,951
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- UDI-DI: 00607567100008 Lot Numbers: 3000188485
- 3000193165
- 3000193670
- 3000195673
- 3000198652
- 3000199944
- 3000201253
- 3000204442
Distribution
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