# FDA recall Z-1708-2019

> **Stryker Neurovascular** · Class II · device recall initiated 2019-04-18.

## Product

Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876):    a) REF: INC-11196-70, 70cm,  b) REF: INC-11196-80, 80cm,  c) REF: INC-11196-90, 90cm    Product Usage:  Indications for Use: The AXS Infinity LS Plus Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. Device Description: The AXS Infinity LS Plus Long Sheath is a single lumen, flexible, variable stiffness long sheath with an 0.091 inch inner diameter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Infinity LS Plus Long Sheath shaft has a 10 cm lubricious coating at the distal end to reduce friction during use. The inner lumen of the AXS Infinity LS Plus Long Sheath is compatible with 6F or smaller catheters. Each package includes one AXS Infinity LS Plus Long Sheath (INC- 11196-70, INC-11196-80, or INC-11196-90), one Dilator, and one hemostas

## Reason for recall

A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.

## Distribution

U.S Nationwide Distribution -   PA, VA, TX, CA, FL, AR, TN, MI, NY, IL, NC, KY, WV, OH, MO, AZ, GA, WA, VT, DC, SC, NJ, MN, OK, MD, AL, LA, MA, DE, IN, OR, RI, SD, MS, WI, ID, UT, CO, IA, KS, CT, NE, NM

## Key facts

- **Recall number:** Z-1708-2019
- **Recalling firm:** Stryker Neurovascular
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-18
- **Report date:** 2019-06-12
- **Termination date:** 2021-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fremont, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1708-2019

## Citation

> AI Analytics. FDA recall Z-1708-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1708-2019. Source: US FDA. Licensed CC0.

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