Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55D
FDA device recall Z-2106-2025 · posted 2025-07-10 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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.
- 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.
- Root cause
- Packaging change control
- Status
- Open, Classified
- Product code
- DXF
- Quantity affected
- 14,724
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
- Date initiated
- 2025-06-10
- Date posted
- 2025-07-10
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VersaCross Transseptal Sheath (K183655) | Baylis Medical Company, Inc. | 2019-05-20 |