Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F… recallZ-1397-2023 · Boston Scientific Corporation · initiated Feb 2, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-1397-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 2, 2023
- Posted by the FDA
- Apr 18, 2023
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 6635 units US: 1815 US units; 4820 OUS units
- Product code
- KNS
- FDA submissions
- K083292
- 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.
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
Code information (models, lots, serial numbers)
GTIN: 8714729981909 All lots , All Expiration Dates
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Habib™ EndoHPB M00500070Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall1 death31 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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