Acrobat-i Vacuum Positioner System Recalled for Positioner Arm Locking Failure
Maquet Cardiovascular is recalling the Acrobat-i Vacuum Positioner System because the positioner arm may fail to tighten or lock during normal use, which could affect surgical positioning.
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: This is a Class II medical device recall involving a functional defect in a surgical positioning system that could prevent proper patient positioning during cardiovascular procedures. No injuries or hospitalizations have been reported, but the risk-of-harm nature of the defect warrants a High severity rating.
Plain-English summary
The Acrobat-i Vacuum Positioner System, Model XP-5000Z, manufactured by Maquet Cardiovascular, is being recalled due to a functional defect in the positioner arm. The arm may not tighten or lock properly during normal use, which could compromise the device's ability to maintain patient positioning during cardiovascular procedures.
A failure of the positioner arm to lock could allow unintended patient movement during surgery, potentially affecting the surgical outcome and patient safety. This defect applies to 6,472 units that have been distributed nationwide in the United States and globally.
Healthcare facilities and users of this device should immediately discontinue use of affected units. Contact Maquet Cardiovascular for replacement devices, repair options, or instructions for the affected lot numbers: 3000195267, 3000195268, 3000195273, 3000195663, 3000199248, 3000199725, 3000204637, 3000207240, 3000211594, 3000212053, 3000213219, 3000214053, 3000214054, 3000214255, 3000221064, 3000214052, 3000225770, 3000226531, 3000225866, 3000225769, 3000231209, 3000231210.
The recalled product
- Product
- Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
- Manufacturer
- Maquet Cardiovascular, LLC
- Affected units
- 6,472
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)
- UDI-DI: 00607567500006
- Lot Numbers: 3000195267
- 3000195268
- 3000195273
- 3000195663
- 3000199248
- 3000199725
- 3000204637
- 3000207240
- 3000211594
- 3000212053
- 3000213219
- 3000214053
- 3000214054
- 3000214255
- 3000221064
- 3000214052
- 3000225770
- 3000226531
- 3000225866
Distribution
Distributed nationwide across the United States.
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