TorFlex Transseptal Guiding Sheath recallZ-2106-2025 · Boston Scientific Corporation · initiated Jun 10, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Packaging change control
What the company is doing
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.
Recall details
- Recall number
- Z-2106-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 10, 2025
- Posted by the FDA
- Jul 10, 2025
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 14,724
- Product code
- DXF
- FDA submissions
- K183655
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
Product description
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.
Code information (models, lots, serial numbers)
TF85-32-63-45 UDI-DI 00685447005391 Lots 35508747 35644132 35746496 35913449; TF85-32-63-55 UDI-DI 00685447005407 Lots 35508748 35738145
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- TorFlex Transseptal Guiding Sheath TF85-32-63-45Boston Scientific Corporation · Introducer, Catheter1 recall12 reports
- TorFlex Transseptal Guiding Sheath TF85-32-63-55Boston Scientific Corporation · Introducer, Catheter1 recall1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97036).
- Z-2103-2025 · Open, ClassifiedVersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/…
- Z-2105-2025 · Open, ClassifiedVersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introductio…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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