Imager II 5F Angiographic Catheters — Class I medical device recall Z-1555-2020
Ongoing recall by Boston Scientific Corporation, reported 2020-04-01, distributed nationwide. Potential for tip detachment of Imager II 5F Angiographic Catheters
| Recall number | Z-1555-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2020-02-11 |
| Classified | 2020-03-25 |
| Reported by FDA | 2020-04-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CH, CN, CO, CY, CZ, DE, ES, FI, FR, GB, GR, HR, HU, ID, IL, IN, IT, JO, JP, KR, LB, LT, MX, MY, NL, NO, PL, RU, SE, SK, TR, TW, ZA |
| Quantity | 1,068,827 single |
| Reason classes | device malfunction |
Product
Imager II 5F Angiographic Catheters, 5 units per package.
Reason for recall
Potential for tip detachment of Imager II 5F Angiographic Catheters
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-1555-2020. 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.