Acrobat-i Positioner — Class II medical device recall Z-0484-2025
Ongoing recall by Maquet Cardiovascular, LLC, reported 2024-11-27, distributed nationwide. Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot
| Recall number | Z-0484-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2024-10-16 |
| Classified | 2024-11-18 |
| Reported by FDA | 2024-11-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BD, BE, BH, CA, CH, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HK, HR, ID, IN, IT, JP, KR, LB, LU, MY, NL, OM, PK, PL, PT, SI, TR, ZA |
| Quantity | 14,338 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00607567500006 |
| Lot numbers | 3000272452, 3000272461, 3000273855, 3000276339, 3000278266, 3000282355, 3000282741, 3000286557, 3000287205, 3000288356, 3000289270, 3000290350, 3000290368, 3000293675, 3000293958, 3000300092, 3000306394, 3000306920, 3000306921, 3000307458, 3000308238, 3000311731, 3000317546, 3000318694, 3000334128, 3000334322, 3000340401, 3000340972, 3000343116, 3000343467, 3000346421, 3000347351, 3000347358, 3000352249, 3000353846, 3000355318, 3000355540, 3000360175, 3000360292, 3000360569 and 11 more |
| Model numbers | C-XP-5000Z |
Product
Acrobat-i Positioner. Model Number C-XP-5000Z
Reason for recall
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
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-0484-2025. 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.