Stryker Neurovascular — Class II medical device recall Z-1620-2020
Terminated recall by Stryker Neurovascular, reported 2020-04-08, distributed nationwide. The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if i
| Recall number | Z-1620-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2019-04-10 |
| Classified | 2020-03-31 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2021-02-25 |
| Distributed | Nationwide (US) |
| Quantity | 1,405 products |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07613327459210, 07613327459227, 07613327459234 |
| Lot numbers | 13131-01, 13156-01, 13158-01, 13163-01, 13170-01, 13176-01, 13200-01, 13201-01, 13208-01, 13212-01, 13213-01, 13215-01, 13221-01, 13222-01, 13238-01, 13260-01, 13266-01, 13289-01, 13301-01, 13302-01, 13410-01, 13412-01, 13494-01, 13500-01, 13520-01, 13530-01, 13543-01, 13545-01 |
| Model numbers | INC-11129-115, INC-11129-125, INC-11129-132 |
| Expiration dates | 2021-11-29 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1620-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.