—#198889

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

FDA product code: KNS — Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K083292
Affected lot / code info: GTIN: 8714729981909 All lots , All Expiration Dates

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").

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2023-02-02
Posted by FDA: 2023-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198889. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.