Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.
This recall is currently active, issued July 10, 2025. It was issued by Boston Scientific Corporation.
- Company
- Boston Scientific Corporation
- Recall Initiated
- June 10, 2025
- Posted
- July 10, 2025
- Recall Number
- Z-2106-2025
- Quantity
- 14,724
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
Lot / Code Info
TF85-32-63-45 UDI-DI 00685447005391 Lots 35508747 35644132 35746496 35913449; TF85-32-63-55 UDI-DI 00685447005407 Lots 35508748 35738145
Root Cause
Packaging change control
Action Taken
On June 10, 2025, the firm began notifying consignees of the field action via Urgent Medical Device Removal letters. Customers are instructed to not use affected product. They should remove affected units from their inventory and segregate the units in a secure place until they can be returned to Boston Scientific.