{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Fremont",
      "address_1": "47900 Bayside Pkwy",
      "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.",
      "address_2": "",
      "product_quantity": "2435",
      "code_info": "All lots",
      "center_classification_date": "20190602",
      "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",
      "state": "CA",
      "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.",
      "report_date": "20190612",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Stryker Neurovascular",
      "recall_number": "Z-1708-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "82755",
      "termination_date": "20210427",
      "more_code_info": "",
      "recall_initiation_date": "20190418",
      "postal_code": "94538-6515",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}