FDA Medical Device Recalls (openFDA)
Stryker Neurovascular: 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.
- Recall number
- Z-1621-2020
- Recalling firm
- Stryker Neurovascular
- 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.
- Status
- Terminated
- Initiated
- 2019-04-10
- Posted
- not on file
- Terminated
- 2021-02-25
- Reason
- 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
- 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 NVCustomerCare@Stryker.com.
- Quantity
- 1405 total devices
- 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.
- Lot, serial or model codes
- Catalog # INC-11597-115: (Lot # 13728-01) Catalog # INC-11597-125: (Lot # 13730-01) Catalog # INC-11597-132: (Lot # 13732-01)
- 510(k) numbers
- ["K181354"]
- PMA numbers
- not on file
- Product code
- NRY
- Firm FEI
- 3008853977
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28