# FDA recall Z-2735-2018

> **Boston Scientific Corporation** · Class II · device recall initiated 2017-12-11.

## Product

Boston Scientific Guider Softip XF Guide Catheter     Product Usage:  Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip and a hub/strain relief combination for kink resistance (at the hub), device connectivity, and device handling.

## Reason for recall

Potential polymer material degradation.

## Distribution

Worldwide - US Nationwide Distribution - AL, FL, IL, IN, KY, MA, MI, MN, MS, NC, NV, NY, OH, OR, TN, TX, UT,  WA  and the country CANADA

## Key facts

- **Recall number:** Z-2735-2018
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-11
- **Report date:** 2018-08-15
- **Termination date:** 2019-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2735-2018

## Citation

> AI Analytics. FDA recall Z-2735-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2735-2018. Source: US FDA. Licensed CC0.

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