# FDA recall Z-2106-2025

> **Boston Scientific Corporation** · Class II · device recall initiated 2025-06-10.

## 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.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.

## Key facts

- **Recall number:** Z-2106-2025
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-10
- **Report date:** 2025-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2106-2025

## Citation

> AI Analytics. FDA recall Z-2106-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2106-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*