Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar ene

FDA device recall Z-1397-2023 · posted 2023-04-18 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

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").

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KNS

Quantity affected

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

Date initiated

2023-02-02

Date posted

2023-04-18

Location

Marlborough, MA

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