# FDA recall Z-2103-2025

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

## Product

VersaCross Access Solution (VXSK),  Product Description and ID:    VXSK (180J RF WIRE 63CM/45DEG/D0)  VXSK0101  VXSK (180J RF WIRE 63CM/45DEG/D1)  VXSK0102  VXSK (180J RF WIRE 63CM/55DEG/D0)  VXSK0103  VXSK (180P RF WIRE 63CM/45DEG/D0)  VXSK0121  VXSK (180P RF WIRE 63CM/45DEG/D1)  VXSK0122  VXSK (180P RF WIRE 63CM/55DEG/D0)  VXSK0123  VXSK (180P RF WIRE 63CM/55DEG/D1)  VXSK0124  VXSK (180P RF WIRE 63CM/90DEG/D0)  VXSK0125  VXSK (230J RF WIRE 63CM/45DEG/D0)  VXSK0111  VXSK (230J RF WIRE 63CM/45DEG/D1)  VXSK0112  VXSK (230P RF WIRE 63CM/45DEG/D0)  VXSK0131  VXSK (230P RF WIRE 63CM/45DEG/D1)  VXSK0132  VXSK (230P RF WIRE 63CM/55DEG/D0)  VXSK0133  VXSK (230P RF WIRE 63CM/55DEG/D1)  VXSK0134  VXSK (230P RF WIRE 81CM/45DEG/D0)  VXSK0137  VXSK-180P RF WIRE 63CM/45DEG/D0 SHEATH  VXSK0021  VXSK-180P RF WIRE 63CM/45DEG/D1 SHEATH  VXSK0022  VXSK-180P RF WIRE 63CM/55DEG/D1 SHEATH  VXSK0024  VXSK-180P RF WIRE 63CM/90DEG/D0 SHEATH  VXSK0025  VXSK-230P RF WIRE 63CM/45DEG/D0 SHEATH  VXSK0031  VXSK-230

## 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-2103-2025
- **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-2103-2025

## Citation

> AI Analytics. FDA recall Z-2103-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2103-2025. Source: US FDA. Licensed CC0.

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