Maquet Universal Frame Recalled Due to Thromboembolic Event Reports
Maquet is recalling Universal Frames and Adjustable Positioning Elements after two serious thromboembolic events were reported during lumbar spine surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly reports two serious thromboembolic events, which aligns with the rubric criterion for 'significant injury reports' and the agency's Class II classification.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling the Universal Frame for Positioning Patients (Part Number 1007.24F0) and Adjustable Positioning Elements (Part Number 1007.28A0). The recall involves 3 sets in the United States and 47 sets distributed internationally.
The recall was initiated after two serious thromboembolic events were reported involving these devices during lumbar spine surgery. The FDA determined that the hip elements may negatively affect venous backflow under certain conditions, which may have contributed to the reported events.
Healthcare facilities that have received these products should stop using them and contact Maquet Cardiovascular US Sales, LLC for instructions on return or replacement. The affected products were distributed in the US (including Alabama, California, and Missouri) and internationally to Australia, Brazil, Canada, China, Croatia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Russia, Singapore, South Africa, and the United Arab Emirates.
The recalled product
- Product
- Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after…
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
Distribution
Part of a larger recall action
This product is one of 2 recalled by Maquet Cardiovascular Us Sales, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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