—#214336

Product

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.

FDA product code: DXF — Catheter, Septostomy
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K183655
Affected 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

Why it was recalled

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.

Root cause (FDA determination)

Packaging change control

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.

Timeline

Recall initiated: 2025-06-10
Posted by FDA: 2025-07-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214336. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.