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Use caution Medical device recall · FDA · Published April 10, 2019

Stryker Neurovascular AXS Vecta 71 Catheter Recall: Risk of Breakage or Kinking

Stryker Neurovascular recalls AXS Vecta 71 Aspiration Catheters (Catalog # INC-11129-115, 125, 132) due to potential breakage or kinking if improperly removed from packaging or during use. Affected units have a use-by date of 2021-11-29.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1620-2020Medical deviceStryker Neurovascular ›
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Contact the company

Recalling firmStryker Neurovascular47900 Bayside Pkwy · Fremont, CA 94538-6515
✎ GovInfoNow plain-language explainer

What happened, in plain English

Stryker Neurovascular is recalling AXS Vecta 71 Aspiration Catheters that may break or kink if not handled properly during removal from packaging or use. This could lead to complications during medical procedures, especially for stroke patients. Read more at govinfonow.com/recall/68366-stryker-neurovascular-axs-vecta-71-catheter-recall-risk-of-breakage.

Source Summary by GovInfoNow · govinfonow.com/recall/68366-stryker-neurovascular-axs-vecta-71-catheter-recall-risk-of-breakage · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1620-2020

Cite this page

“Stryker Neurovascular AXS Vecta 71 Catheter Recall: Risk of Breakage or Kinking.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68366-stryker-neurovascular-axs-vecta-71-catheter-recall-risk-of-breakage. Based on FDA recall #Z-1620-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1620-2020%22&limit=1).

Why it’s dangerous

The catheters can break or kink if not removed correctly from the packaging or during medical use. This could cause complications during stroke treatment, potentially leading to ineffective procedures or additional health risks.

Who’s affected

Healthcare professionals who use these catheters for stroke treatment and patients prescribed the product by a doctor. Those handling the catheters without proper technique are at higher risk.

How to tell if you have this one

Check for the product name 'AXS Vecta 71 Aspiration Catheter' with catalog numbers INC-11129-115, 125, or 132. The use-by date is 2021-11-29. The product is for prescription use only and requires sterile handling.

  • Brand
    Stryker Neurovascular
  • Product
    Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US Nationwide distribution in the states of PA, FL, CA, IL, WI, AZ, AR, FL, TN, MI, MA, CA, NC, WV, DE, OH, NJ, MO, NY, SC, TX, AL, VA, UT, MD, GA, LA, CO, WA, KY, OK, RI, SD, MS, NE,IA, KS, DC. No US Govt. No Foreign countries.
Recall numberProduct, codes & lotsQuantity
Z-1620-2020Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459210(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-125, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459227(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-132, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459234(17)211129(10)00000-00 Product Usage: The AXS Vecta Aspiration System, including the AXS Vecta Aspiration Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.; Catalog # INC-11129-115: (Lot #'s 13170-01,13301-01,13494-01,13543-01,13545-01) Catalog # INC-11129-125: (Lot #'s 13163-01,13302-01,13500-01,13530-01) Catalog # INC-11129-132: (Lot #'s 13131-01,13156-01,13158-01,13176-01,13200-01,13201-01,13208-01,13212-01,13213-01,13215-01,13222-01,13238-01,13260-01,13266-01,13289-01,13221-01,13410-01,13412-01,13520-01)1405 total products
Z-1621-2020Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459241(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-125, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459258(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-132, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459265(17)211129(10)00000-00 Product Usage: The AXS Vecta Aspiration System, including the AXS Vecta Aspiration Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.; Catalog # INC-11597-115: (Lot # 13728-01) Catalog # INC-11597-125: (Lot # 13730-01) Catalog # INC-11597-132: (Lot # 13732-01)1405 total devices
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the catalog number and use-by date on the packaging to confirm if the product is affected.

  2. Stop Using if Uncertain

    If you have the catheter and are unsure of the catalog number or use-by date, stop using it immediately and contact Stryker Neurovascular for guidance.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 35 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of PA, FL, CA, IL, WI, AZ, AR, FL, TN, MI, MA, CA, NC, WV, DE, OH, NJ, MO, NY, SC, TX, AL, VA, UT, MD, GA, LA, CO, WA, KY, OK, RI, SD, MS, NE,IA, KS, DC. No US Govt. No Foreign countries.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: Apr 10, 201912. FDA classified it Class II: Mar 31, 202023. Published in FDA’s Enforcement Report: Apr 8, 202034. FDA terminated the recall: Feb 25, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1620-2020 (April 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1620-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA