Torflex transseptal guiding sheath kits may have a punctured sterile pouch
Torflex Transseptal Guiding Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Risk-of-harm product: a compromised sterile barrier on a cardiovascular access device, with no infection reported in the source.
Plain-English summary
The Torflex Transseptal Guiding Sheath Kit (TFK-M), covering TF85-32-63-45 (Torflex 8.5F 63 cm 45 degree) and TF85-32-63-55 (Torflex 8.5F 63 cm 55 degree), used for the percutaneous introduction of various types of cardiovascular catheters and guidewires, is being recalled. The action covers 14,724 units.
According to the manufacturer, there is a potential for a hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. The manufacturer states the issue could potentially lead to systemic infection and sepsis in a worst case scenario, and that potential punctures may go undetected in clinical settings due to their small size and variable location. The FDA classified the action as Class II. The source does not report any infection having occurred.
Distribution was worldwide, including nationwide in the United States and to Canada and Hong Kong among other markets.
Facilities should identify affected stock using the model numbers, UDI-DI codes and lot numbers in the recall notice and follow the instructions issued by the manufacturer.
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…
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 14,724
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.
Part of a larger recall action
This product is one of 4 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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