Stryker Neurovascular: Medical Device Recall in 2019 - (Recall #: Z-1708-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 hemostasis valve. Dimensions of the AXS Infinity LS Plus Long Sheath are included on the individual device label.

Product Classification:

Class II

Date Initiated: April 18, 2019

Date Posted: June 12, 2019

Recall Number: Z-1708-2019

Event ID: 82755

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.

Status: Terminated

Product Quantity: 2435

Code Information:

All lots

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated