Habib EUS RFA — Class II medical device recall Z-0668-2020
Terminated recall by Boston Scientific Corporation, reported 2019-12-18, distributed nationwide. During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA need
| Recall number | Z-0668-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2019-11-18 |
| Classified | 2019-12-11 |
| Reported by FDA | 2019-12-18 |
| Terminated | 2020-06-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, ES, GB, GR, IN |
| Quantity | 179 |
| UPC / GTIN / UDI-DI | 05060271140596 |
| Lot numbers | 17-C01 |
| Expiration dates | 2020-07-10, 2020-11-12, 2021-02-18, 2021-02-19 |
Product
Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
Reason for recall
During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.
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-0668-2020. 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.