FDAClass IIDecember 27, 2023

Acrobat-i Vacuum Positioner System recall

Acrobat-i Vacuum Positioner System, Model Number XP-5000Z

Why was Acrobat-i Vacuum Positioner System recalled?

The Positioner Arm may not tighten or lock during normal use.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 00607567500006; Lot Numbers: 3000195267, 3000195268, 3000195273, 3000195663, 3000199248, 3000199725, 3000204637, 3000207240, 3000211594, 3000212053, 3000213219, 3000214053, 3000214054, 3000214255, 3000221064, 3000214052, 3000225770, 3000226531, 3000225866, 3000225769, 3000231209, 3000231210

Product
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
Recalling firm
Maquet Cardiovascular, LLC
Quantity
6472 units
Distribution
US Nationwide. Global Distribution.
Recall date
December 27, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls