Stryker Neurovascular: Medical Device Recall in 2018 - (Recall #: Z-3281-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 2, 2018

Date Posted: October 10, 2018

Recall Number: Z-3281-2018

Event ID: 80652

Reason for Recall:

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

Status: Terminated

Product Quantity: 15 units

Code Information:

Lot No. 20156091 ;UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated