Use cautionMedical device recall · FDA · Published June 10, 2025
Boston Scientific Torflex Sheath Kit Recall: Risk of Sterile Pouch Compromise
Boston Scientific recalls Torflex Transseptal Guiding Sheath Kits with potential sterile pouch holes causing infection. Affected models include TF85-32-63-45 and TF85-32-63-55. Contact for remedy.
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.
Take action
Contact the company
📍Recalling firmBoston Scientific Corporation4100 Hamline Ave N · Saint Paul, MN 55112-5700
“Boston Scientific Torflex Sheath Kit Recall: Risk of Sterile Pouch Compromise.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52090-boston-scientific-torflex-sheath-kit-recall-risk-of-sterile-pouch. Based on FDA recall #Z-2106-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2106-2025%22&limit=1).
The FDA announced on June 10, 2025, that Boston Scientific Corporation is recalling Torflex Transseptal Guiding Sheath Kits due to potential holes in the sterile barrier pouch. This defect may compromise device sterility and lead to systemic infection or sepsis.
Distribution: Worldwide, including US, Canada, Hong Kong, and Japan
Units affected: 14,724
The hazard
The recall addresses potential holes in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. The FDA states this issue could potentially lead to systemic infection and sepsis in the worst-case scenario. Potential punctures may go undetected in clinical settings due to their small size and variable location.
Context
GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent brand recalls include the Imager II Angiographic Catheters Recall (August 24, 2026) for tip fracture risk and the LUX-Dx Cardiac Monitor System Recall (August 6, 2026) for delayed AF burden alerts. Other recent recalls of similar products include the Vortex Surgical Convenience Kits Recall (December 16, 2025), the Vortex Surgical I2 Injection Kit Recall (December 16, 2025), and the Boston Scientific Intracept Access Instruments Recall (April 22, 2026) for risk of sterility breach.
How to tell if you have this one
Check for model numbers TF85-32-63-45 or TF85-32-63-55 on the kit packaging. The kits are sold with specific lot numbers listed in the recall notice.
Brand
Boston Scientific
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.; UDI-DI 00685447006121 Lot 35935598
Z-2105-2025
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J 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.; VXS0201 UDI-DI 00685447020301 Lot 35800622; VXS2112 UDI-DI 00685447019251 Lot 35892045
Z-2106-2025
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.; TF85-32-63-45 UDI-DI 00685447005391 Lots 35508747 35644132 35746496 35913449; TF85-32-63-55 UDI-DI 00685447005407 Lots 35508748 35738145
Based on the official FDA remedy
What to do — step by step
Check Kit Model
Identify the model number on the kit packaging to confirm if it is affected.
Contact Manufacturer
Reach out to Boston Scientific for instructions on how to handle the recalled kit.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 36 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2106-2025 (June 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2106-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.