Data Foundry

Medical device recalls 2023

Acrobat-i Vacuum Positioner System — Class II medical device recall Z-0589-2024

Ongoing recall by Maquet Cardiovascular, LLC, reported 2023-12-27, distributed nationwide. The Positioner Arm may not tighten or lock during normal use.

Recall numberZ-0589-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMaquet Cardiovascular, LLC, Wayne, NJ, United States
Recall initiated2023-10-31
Classified2023-12-19
Reported by FDA2023-12-27
DistributedNationwide (US)
Quantity6,472 units
UPC / GTIN / UDI-DI00607567500006
Lot numbers3000195267, 3000195268, 3000195273, 3000195663, 3000199248, 3000199725, 3000204637, 3000207240, 3000211594, 3000212053, 3000213219, 3000214052, 3000214053, 3000214054, 3000214255, 3000221064, 3000225769, 3000225770, 3000225866, 3000226531, 3000231209, 3000231210
Model numbersXP-5000Z

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0589-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.