Torflex Transseptal Guiding Sheath Kit — Class II medical device recall Z-2106-2025
Ongoing recall by Boston Scientific Corporation, reported 2025-07-16, distributed nationwide. Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Iss
| Recall number | Z-2106-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2025-06-10 |
| Classified | 2025-07-10 |
| Reported by FDA | 2025-07-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HK, JP |
| Quantity | 14,724 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00685447005391, 00685447005407 |
| Lot numbers | 35508747, 35508748, 35644132, 35738145, 35746496, 35913449, TF85-32-63-55 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2106-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.