Recall Z-1708-2019— Stryker Neurovascular

Name: FDA recall Z-1708-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-18

Class II · Terminated

Class II FDA medical device recall by Stryker Neurovascular, initiated 2019-04-18, terminated 2021-04-27. It names one FDA 510(k) clearance: K172468. 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 hemostasis valve. Dimensions of the AXS Infinity LS Plus Long Sheath are included on the individual device label.. Reason: A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft..

Recalling firm: Stryker Neurovascular
Classification: Class II
Status: Terminated
Initiated: 2019-04-18
Terminated: 2021-04-27
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K172468 — 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cmInneuroco, Inc.·cleared 2017-12-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.