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U.S. Department of Health and Human Services

Class 2 Device Recall AXS Vecta 74 Aspiration Catheter

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 Class 2 Device Recall AXS Vecta 74 Aspiration Cathetersee related information
Date Initiated by FirmApril 10, 2019
Create DateMarch 31, 2020
Recall Status1 Terminated 3 on February 25, 2021
Recall NumberZ-1621-2020
Recall Event ID 84780
510(K)NumberK181354 
Product Classification Catheter, thrombus retriever - Product Code NRY
ProductStryker 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.
Code Information Catalog # INC-11597-115: (Lot # 13728-01) Catalog # INC-11597-125: (Lot # 13730-01) Catalog # INC-11597-132: (Lot # 13732-01)
FEI Number 3008853977
Recalling Firm/
Manufacturer		 Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Component design/selection
ActionOn 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.
Quantity in Commerce1405 total devices
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NRY
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