Z-1620-2020Class II

Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29...

Name: Z-1620-2020 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29...
Creator: Stryker Neurovascular
Published: 2019-04-10
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2019-04-10 / Terminated / root cause: design

FDA source

Stryker Neurovascular began a recall of 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... on 2019-04-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1620-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-10
Posted: 2020-03-31
Terminated: 2021-02-25
Recalling firm: Stryker Corp.
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.
Product code: NRY Catheter, Thrombus Retriever
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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 [email protected].
Quantity in commerce: 1405 total products
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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1620-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1620-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-31
Z-1621-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-31

Product code NRY

K172167Class IIZenith Flex SystemInneuroco, Inc. / cleared 2018-04-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)