Acrobat SUV Vacuum Stabilizer System Sterile Barrier Compromise Recall
Maquet Cardiovascular is recalling the Acrobat SUV Vacuum Stabilizer System (Model C-OM-9000Z) due to manufacturing deviations that compromise the sterile barrier. Sterility cannot be assured during the 2-year shelf life, affecting approximately 10,778 units.
What this means for you
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: This is an FDA Class II recall of a surgical device where manufacturing deviations compromise the sterile barrier, creating a theoretical infection risk. No illnesses, injuries, hospitalizations, or adverse events are reported. Per the rubric, a Class II recall of risk-of-harm products without reported injury receives a severity score of 3 (High).
Plain-English summary
The Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z, manufactured by Maquet Cardiovascular, LLC, is being recalled due to deviations in the manufacturing process that have compromised the sterile barrier of the device.
Deviations during manufacturing created a compromise in the sterile barrier, preventing sterility assurance throughout the product's 2-year shelf life. This poses a potential risk of infection if contaminated devices are used in clinical settings.
The recall affects approximately 10,778 units distributed nationwide in the United States and internationally to multiple countries including Canada, the United Kingdom, Japan, Germany, France, and others. Affected devices can be identified by Model Number C-OM-9000Z and UDI-DI Number 00607567900004, along with specific batch numbers.
Healthcare facilities should check their inventory against the provided batch numbers and quarantine affected devices per facility protocols. For the complete list of affected batch numbers and additional guidance, refer to FDA recall Z-0485-2025.
The recalled product
- Product
- Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- sterile-barrier-compromise
- infection-risk
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 (20)
- 3000274130
- 3000279333
- 3000325028
- 3000349295
- 3000356305
- 3000368568
- 3000288446
- 3000314841
- 3000318197
- 3000340989
- 3000315179
- 3000284660
- 3000279342
- 3000325025
- 3000340964
- 3000274640
- 3000280059
- 3000280563
- 3000325362
- 3000284695
Distribution
Distributed nationwide across the United States.
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