MAMBA Microcatheter — Class II medical device recall Z-1430-2021
Terminated recall by Boston Scientific Corporation, reported 2021-04-21, distributed nationwide. The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrec
| Recall number | Z-1430-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2021-03-05 |
| Classified | 2021-04-15 |
| Reported by FDA | 2021-04-21 |
| Terminated | 2023-01-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, FR, GB, IL, IT, LT, NL, PL |
| Quantity | 63 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 08714729940241, 08714729940265 |
| Lot numbers | 26578155, 26578465 |
| Expiration dates | 2023-01-04 |
Product
MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
Reason for recall
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
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-1430-2021. 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.