Maquet Adjustable Positioning Elements Recalled Due to Thromboembolic Events
Maquet is recalling Adjustable Positioning Elements used in spine surgery after two serious thromboembolic events were reported.
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 recall is classified as Severe (Score 4) because the source text explicitly reports two serious thromboembolic events, which aligns with the rubric criterion for 'significant injury' reports.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling the Adjustable Positioning Elements (Part Number 1007.28A0) and Universal Frame (Part Number 1007.24F0). These patient positioners are designed to stabilize patients in the prone position during surgical interventions, specifically for spine procedures with dorsal access.
The recall was initiated after two serious thromboembolic events were reported involving these devices during lumbar spine surgery. The FDA notes that the hip elements of the positioning system may negatively affect venous backflow under certain conditions, which may have contributed to the reported events.
The affected units were distributed worldwide, including in the United States (3 sets) and internationally to 16 other countries. Healthcare facilities and users should stop using the affected devices and contact Maquet for instructions on return or replacement.
The recalled product
- Product
- Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and…
- 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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