Recall Z-1397-2023 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Boston Scientific Corporation
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
| Date | Apr 18, 2023 (initiated Feb 2, 2023) |
| Status | Open, Classified |
| 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"). |
| Root cause | Under Investigation by firm |
| Action | Boston Scientific issued Urgent Medical Device Field Safety Notice - Immediate Action Required Habib" EndoHPB Bipolar Radiofrequency Catheter IFU Generator Setting to US and Puerto Rico consignees sent via Federal Express Priority Overnight mail on March 2, 2023. Letter states reason for recall, health risk and provides important information about the use of the Habib EndoHPB Catheter when used with the ERBE VIO 3 Generator. Habib EndoHPB Catheter users should cease use with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or |
| Quantity | 6635 units US: 1815 US units; 4820 OUS units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Czech Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, Iraq, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lithuania, Mexic |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083292 | HABIB ENDOHPB Emcision , Ltd., Jun 10, 2009 |