FDA Device recall Z-1397-2023
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm)
- FDA Device
- Class II
- ongoing
- Published 2023-04-26
On 2023-04-26 the FDA classified a Class II recall of Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm) by Boston Scientific, citing 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 tiss….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1397-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-02 |
| Published | 2023-04-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | US |
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
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").
Identifiers
| code_info | GTIN: 8714729981909 All lots , All Expiration Dates |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1397-2023%22
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