medical Class II Updated 2020-04-08

Stryker Neurovascular recalls Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref

Recalled Product

Stryker 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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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)
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Related medical Recalls

Boston Scientific Corporation recalls Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Cathete

2022-08-31 · The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

Mckesson Medical-Surgical Inc. Corporate Office recalls MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, w

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

GE Healthcare, LLC recalls (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (

2022-08-31 · Inaccurate Distance and Area measurements with use of Global Stack viewport.

Mckesson Medical-Surgical Inc. Corporate Office recalls B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY,

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.