Maquet Cardiovascular, LLC is recalling 58,939 units of its Acrobat positioners and stabilizers, including the Acrobat-i Positioner, Acrobat SUV Vacuum Stabilizer System, and Acrobat-i Vacuum Stabilizer System. These medical devices, used during cardiac surgery, are being recalled because manufacturing issues compromised the sterile barrier of the packaging. As a result, the sterility of the devices cannot be guaranteed for the full duration of their two-year shelf life. No injuries or incidents have been reported at this time.
A compromised sterile barrier means the devices may be contaminated when used in a surgical setting. Using non-sterile equipment during invasive cardiac procedures poses a significant risk of infection, sepsis, and other serious surgical complications for the patient.
Recall #: Z-0484-2025. Sterile barrier compromised by manufacturing deviation.
Recall #: Z-0485-2025. Sterile barrier compromised by manufacturing deviation.
Recall #: Z-0486-2025. Sterile barrier compromised by manufacturing deviation.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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