Recall Z-1397-2023— Boston Scientific Corporation

Name: FDA recall Z-1397-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-02

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2023-02-02. It names one FDA 510(k) clearance: K083292. 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")..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-02-02
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K083292 — HABIB ENDOHPBEmcision , Ltd.·cleared 2009-06-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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").

Data sourced from openFDA. This site is unofficial and independent of the FDA.