—#179355

Product

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 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.

FDA product code: NRY — Catheter, Thrombus Retriever
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K181354
Affected lot / code info: Catalog # INC-11597-115: (Lot # 13728-01) Catalog # INC-11597-125: (Lot # 13730-01) Catalog # INC-11597-132: (Lot # 13732-01)

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

On 04/11/19, the firm sent an "Urgent: Medical Device Correction" to customers via FedEx with tracking and email to inform them the firm has become aware of a potential problem with its AXS Vecta 71 and 74 Aspiration Catheters may fracture if improperly removed from the packaging. If a user does not pull the catheter straight out of the packaging clip, this may introduce a bend onto the proximal section of the catheter. By applying excessive force, the used can cause a break and/or fracture the catheter shaft. Removing the AXS Vecta Aspiration Catheter correctly - not bending the catheter shaft when removing it from the packaging clip, will help to avoid these issues. This recall affects all lots associated with the AXS Vecta 71 Aspiration Catheter (115cm, 125cm, 132cm) and AXS Vecta 74 Aspiration Catheter (115cm, 125cm, 132cm). The firm is instructing customer to: 1. Not to return this product but to ensure the instructions provided is followed to remove the catheter from its packaging. 2. Circulate this Notice internally to all interested/affected parties. 3. Maintain awareness of this communication internally. 4. Inform the firm if any of the subject devices have been distributed to other organizations. 5. Inform the firm of an adverse events concerning the use of the subject devices. 6. Complete and email the customer response form to acknowledge receipt of the communication to NVCustomerCare@Stryker.com.

Recalling firm

Firm: Stryker Neurovascular
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-04-10
Terminated: 2021-02-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179355. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.