Gore Molding & Occlusion Balloon Catheter — Class II medical device recall Z-2340-2021
Ongoing recall by W. L. Gore & Associates Inc., reported 2021-09-01, distributed nationwide. Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparat
| Recall number | Z-2340-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | W. L. Gore & Associates Inc., Phoenix, AZ, United States |
| Recall initiated | 2021-07-12 |
| Classified | 2021-08-25 |
| Reported by FDA | 2021-09-01 |
| Distributed | Nationwide (US) |
| Quantity | 3,364 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00733132639489 |
| Model numbers | MOB37 |
Product
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
Reason for recall
Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.
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-2340-2021. 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.