Stryker Neurovascular — Class II medical device recall Z-1708-2019
Terminated recall by Stryker Neurovascular, reported 2019-06-12, distributed nationwide. A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in f
| Recall number | Z-1708-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2019-04-18 |
| Classified | 2019-06-02 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2021-04-27 |
| Distributed | Nationwide (US) |
| Quantity | 2,435 |
| Reason classes | device malfunction |
| Model numbers | 70CM, 80CM, 90CM, INC-11196-70, INC-11196-80, INC-11196-90 |
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 for recall
A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1708-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.