Recall Z-2106-2025
Boston Scientific Corporation · initiated June 10, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: TF85-32-63-45 UDI-DI 00685447005391 Lots 35508747 35644132 35746496 35913449; TF85-32-63-55 UDI-DI 00685447005407 Lots 35508748 35738145
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.
FDA-determined 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.
Details
- Recall number
- Z-2106-2025
- Initiated
- June 10, 2025
- Posted by FDA
- July 10, 2025
- Product code
- DXF – Catheter, Septostomy
- Quantity
- 14,724
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
- Recalling firm
- Boston Scientific Corporation, Saint Paul, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2103-2025 Class II | VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE…Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility.… | 06/10/2025Open, Classified |
| Z-2104-2025 Class II | VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the…Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility.… | 06/10/2025Open, Classified |
| Z-2105-2025 Class II | VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS…Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility.… | 06/10/2025Open, Classified |