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U.S. Department of Health and Human Services

Class 2 Device Recall Torflex Transseptal Guiding Sheath Kit

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 Class 2 Device Recall Torflex Transseptal Guiding Sheath Kitsee related information
Date Initiated by FirmJune 10, 2025
Date PostedJuly 10, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2106-2025
Recall Event ID 97036
510(K)NumberK183655 
Product Classification Catheter, septostomy - Product Code DXF
ProductTorflex 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 TF85-32-63-45 UDI-DI 00685447005391 Lots 35508747 35644132 35746496 35913449; TF85-32-63-55 UDI-DI 00685447005407 Lots 35508748 35738145
FEI Number 2124215
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information ContactClara Johnson
651-582-4000
Manufacturer 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.
FDA Determined
Cause 2		Packaging change control
ActionOn 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.
Quantity in Commerce14,724
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DXF
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