Expo 5F Selective Angiographic Catheters — Class I medical device recall Z-1661-2024
Ongoing recall by Boston Scientific Corporation, reported 2024-05-22. An increase in complaints related to an inability to advance the guidewire through the lumen of the device for
| Recall number | Z-1661-2024 |
|---|---|
| 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 | 2024-03-21 |
| Classified | 2024-05-10 |
| Reported by FDA | 2024-05-22 |
| Countries outside the US | CA |
| Quantity | 4,270 catheters |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08714729886082 |
| Lot numbers | 60447162, 60461412, 60474054, 60486303, 60495529, 60511234, 60511248, 60531435 |
| Model numbers | H749085262502, TIG4 |
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter
Reason for recall
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
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-1661-2024. 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.