FDA Device recall Z-0667-2020
Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and abl…
- FDA Device
- Class II
- terminated
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and abl… by Boston Scientific, citing 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 e….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0667-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-18 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
Reason
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.
Identifiers
| code_info | Material Number/UPN: 6500 GTIN: 5060271140725 Batches: 17-C02 (Expiration: 9-Jul-2020), 17-C06 (Expiration: 19-Feb-20…Material Number/UPN: 6500 GTIN: 5060271140725 Batches: 17-C02 (Expiration: 9-Jul-2020), 17-C06 (Expiration: 19-Feb-2021), 17-C07 (Expiration: 19-Feb-2021), 17-C08 (Expiration: 20-Feb-2021) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0667-2020%22
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