Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70 Recalled by Stryker Neurovascular Due to The AXS Infinity LS Long Sheath Dilator outer...

Date: May 2, 2018
Company: Stryker Neurovascular
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Neurovascular directly.

Affected Products

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.

Quantity: 15 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 6 states: CO, NJ, NY, OH, PA, WV

Affected (6 states)Not affected

About Stryker Neurovascular

Stryker Neurovascular has 108 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report