OptiCross Coronary Imaging Catheter — Class II medical device recall Z-1396-2024
Ongoing recall by Boston Scientific Corporation, reported 2024-04-03. Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting,
| Recall number | Z-1396-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2024-03-05 |
| Classified | 2024-03-28 |
| Reported by FDA | 2024-04-03 |
| Countries outside the US | JP |
| Quantity | 239 units |
| UPC / GTIN / UDI-DI | 08714729938415 |
| Lot numbers | 32426901, 32429407, 32625286 |
| Model numbers | H749518080120 |
Product
OptiCross Coronary Imaging Catheter, REF H749518080120
Reason for recall
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
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-1396-2024. 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.