Torflex Transseptal Guiding Sheath Kit recalled for sterile barrier defects
Boston Scientific is recalling Torflex Transseptal Guiding Sheath Kits due to potential holes in the sterile barrier pouch that may compromise device sterility. The defect could lead to systemic infection and sepsis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a high-risk cardiovascular medical device where the potential defect could compromise sterility. No illnesses or injuries have been reported, but the defect poses theoretical risk of systemic infection and sepsis, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling the Torflex Transseptal Guiding Sheath Kit (TFK-M) due to a potential defect affecting device sterility. Approximately 14,724 units have been distributed worldwide, including to the United States, Canada, Hong Kong, and Japan. The affected products include model numbers TF85-32-63-45 and TF85-32-63-55.
The recall involves potential holes in the Tyvek layer of the sterile barrier pouch. These holes may compromise the device's sterility and could potentially go undetected in clinical settings due to their small size and variable location.
This device is used for introducing cardiovascular catheters and guidewires to heart chambers during transseptal procedures. Compromise of the sterile barrier could potentially lead to systemic infection and sepsis.
The recalled product
- 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 atri
- Manufacturer
- Boston Scientific Corporation
- Hazard
- sterile-barrier-breach
- systemic-infection
- sepsis
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- TF85-32-63-45 UDI-DI 00685447005391 Lots 35508747 35644132 35746496 35913449
- TF85-32-63-55 UDI-DI 00685447005407 Lots 35508748 35738145
Distribution
Distributed nationwide across the United States.
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