# FDA recall Z-3281-2018

> **Stryker Neurovascular** · Class II · device recall initiated 2018-05-02.

## Product

AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90)  Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

## Reason for recall

The AXS Infinity LS Long Sheath Dilator  outer diameter (OD) specification was exceeded.

## Distribution

Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.

## Key facts

- **Recall number:** Z-3281-2018
- **Recalling firm:** Stryker Neurovascular
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-02
- **Report date:** 2018-10-10

- **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-3281-2018

## Citation

> AI Analytics. FDA recall Z-3281-2018. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-3281-2018. Source: US FDA. Licensed CC0.

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