Reported Apr 8, 2020 · Terminated
Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only,…
Stryker Neurovascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Neurovascular · 47900 Bayside Pkwy · Fremont, CA · 94538-6515
Is this the product you have?
- Stryker 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 ParkwayFremontCA 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 ParkwayFremontCA 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 ParkwayFremontCA 94538
- UDI(01)07613327459265(17)211129(10)00000-00
- Product UsageThe 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
- Lot codes and dates
- Catalog #
- INC-11597-115(Lot # 13728-01) Catalog #
- INC-11597-125(Lot # 13730-01) Catalog #
- INC-11597-132(Lot # 13732-01)
- Amount recalled
- 1405 total devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter use.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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