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U.S. Department of Health and Human Services

Class 2 Device Recall Habib EndoHPB Bipolar Radiofrequency (RF) Catheter

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  Class 2 Device Recall Habib EndoHPB Bipolar Radiofrequency (RF) Catheter see related information
Date Initiated by Firm February 02, 2023
Date Posted April 18, 2023
Recall Status1 Open3, Classified
Recall Number Z-1397-2023
Recall Event ID 91792
510(K)Number K083292  
Product Classification Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
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
Code Information GTIN: 8714729981909 All lots , All Expiration Dates
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Rebecca Kinkead Rubio
763-494-1133
Manufacturer 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").
FDA Determined
Cause 2		 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 tissue damage as a result of the inaccurate setting currently provided in the HABIB EndoHPB Catheter s Instructions for Use ( IFU ). Boston Scientific recommends that patients who have been treated using the Habib EndoHPB Catheter with the ERBE VIO 3 Generator continue with their regular or routine check-ups and follow-up care. Please read this letter carefully and immediately post this information in a visible location near the product to ensure this information is easily accessible to all users of the device. Share this notice with any health professional within your organization that needs to be aware and to any organization where the potentially affected devices have been transferred. If you are a distributor, this notification must be forwarded to your customers to ensure notification is carried out to the end user level. If you are a facility that has sent products to another hospital or facility within your network, ensure that this notification is forwarded to them. If you have additional questions regarding this information or would like to report a clinical event, please contact your Boston Scientific representative
Quantity in Commerce 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, Mexico, Netherlands, New Zealand, Oman, Panama, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Unit. Arab Emir.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KNS and Original Applicant = EMCISION, LTD.
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