Z-2106-2025Class II

Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX...

Name: Z-2106-2025 Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX...
Creator: Boston Scientific Corporation
Published: 2025-06-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2025-06-10 / Open, Classified / root cause: packaging

FDA source

Boston Scientific Corporation began a recall of 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... on 2025-06-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2106-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-10
Posted: 2025-07-10
Recalling firm: Boston Scientific Corporation
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 atrium via transseptal perforation / puncture.
Product code: DXF Catheter, Septostomy
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.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: 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.
Quantity in commerce: 14,724
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
Product codes and lots: TF85-32-63-45 UDI-DI 00685447005391 Lots 35508747 35644132 35746496 35913449; TF85-32-63-55 UDI-DI 00685447005407 Lots 35508748 35738145

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2106-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2103-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-10
Z-2104-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-10
Z-2105-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-10
Z-2106-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-16	2025-07-10

Product code DXF

K183655Class IIVersaCross Transseptal SheathBaylis Medical Company, Inc. / cleared 2019-05-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)