CLASS II Device recall · Reported 12 Jun 2019 · FDA Enforcement Report
AXS Infinity LS Plus Long Sheath recalled by Stryker Neurovascular
Stryker Neurovascular is recalling AXS Infinity LS Plus Long Sheath, distributed nationwide in the US. The recall was initiated on 18 Apr 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1708-2019
- FDA event ID
- 82755
- Recalling firm
- Stryker Neurovascular, Fremont, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Apr 2019
- FDA classified
- 2 Jun 2019
- Reported
- 12 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 18 Apr 2019 | Recall initiated by company | |
| 2 Jun 2019 | Classified by FDA | +45 days |
| 12 Jun 2019 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
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
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Why was it recalled?
A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.
Which lots are affected?
All lots
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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