CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report

Acrobat-i Vacuum Positioner System recalled by Maquet Cardiovascular

Maquet Cardiovascular is recalling Acrobat-i Vacuum Positioner System, distributed nationwide in the US. The recall was initiated on 31 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled6472 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0589-2024
FDA event ID: 93477
Recalling firm: Maquet Cardiovascular, Wayne, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 31 Oct 2023
FDA classified: 19 Dec 2023
Reported: 27 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

31 Oct 2023	Recall initiated by company
19 Dec 2023	Classified by FDA	+49 days
27 Dec 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

US Nationwide. Global Distribution.

Nationwide

Questions about this recall

Is Acrobat-i Vacuum Positioner System recalled?

Yes. Maquet Cardiovascular recalled Acrobat-i Vacuum Positioner System on 31 Oct 2023. The recall is Class II and its status is Ongoing. Recall number Z-0589-2024.

Why was it recalled?

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

Which lots 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

Where was it sold?

US Nationwide. Global Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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