Habib EndoHPB Bipolar Radiofrequency — Class II medical device recall Z-1397-2023
Ongoing recall by Boston Scientific Corporation, reported 2023-04-26, distributed nationwide. Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potenti
| Recall number | Z-1397-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2023-02-02 |
| Classified | 2023-04-18 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, CA, CH, CR, CZ, DE, EG, ES, FI, FR, GB, GR, HK, HU, IL, IQ, IS, IT, JP, KR, KW, LT, LV, MX, NL, NZ, OM, PA, PL, PT, RO, SA, SE, SI, SK, TH, TW, ZA |
| UPC / GTIN / UDI-DI | 08714729981909 |
Product
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. UPN: M00500070
Reason for recall
Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Catheter's Instructions for Use ("IFU").
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-1397-2023. 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.