{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198889", "product_res_number": "Z-1397-2023", "event_date_initiated": "2023-02-02", "event_date_posted": "2023-04-18", "recall_status": "Open, Classified", "res_event_number": "91792", "product_code": "KNS", "k_numbers": [ "K083292" ], "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.\nUPN: M00500070", "code_info": "GTIN: 8714729981909\nAll lots , All Expiration Dates", "firm_fei_number": "3005099803", "recalling_firm": "Boston Scientific Corporation", "address_1": "100 Boston Scientific Way", "city": "Marlborough", "state": "MA", "postal_code": "01752-1234", "additional_info_contact": "Rebecca Kinkead Rubio \n763-494-1133", "reason_for_recall": "Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the\npotential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Catheter's\nInstructions for Use (\"IFU\").", "root_cause_description": "Under Investigation by firm", "action": "Boston Scientific issued Urgent Medical Device Field Safety Notice - Immediate Action\nRequired Habib\" EndoHPB Bipolar Radiofrequency Catheter IFU Generator\nSetting 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. \n\nPlease read this letter carefully and immediately post this information in a visible\nlocation near the product to ensure this information is easily accessible to all users of\nthe device. Share this notice with any health professional within your organization that\nneeds to be aware and to any organization where the potentially affected devices have\nbeen transferred.\nIf you are a distributor, this notification must be forwarded to your customers to ensure\nnotification 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.\n\nIf you have additional questions regarding this information or would like to report a\nclinical event, please contact your Boston Scientific representative", "product_quantity": "6635 units US: 1815 US units; 4820 OUS units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Czech Republic, Egypt, Finland, \nFrance, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, Iraq, Israel, Italy, \nJapan, Korea, Kuwait, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Oman, Panama, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, \nSouth Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Unit. 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