RecallRadar

FDA Device recall Z-0589-2024

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

On 2023-12-27 the FDA classified a Class II recall of Acrobat-i Vacuum Positioner System, Model Number XP-5000Z by Maquet Cardiovascular, citing the Positioner Arm may not tighten or lock during normal use.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0589-2024
ClassificationClass II
Statusongoing
Initiated2023-10-31
Published2023-12-27
Last updated2026-09-13 11:56 UTC
CompanyMaquet Cardiovascular
DistributionUS

Product

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

Reason

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

Identifiers

code_info
UDI-DI: 00607567500006; Lot Numbers: 3000195267, 3000195268, 3000195273, 3000195663, 3000199248, 3000199725, 3000204637…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0589-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.