# FDA recall Z-1621-2020

> **Stryker Neurovascular** · Class II · device recall initiated 2019-04-10.

## 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 stro

## 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.

## 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.

## Key facts

- **Recall number:** Z-1621-2020
- **Recalling firm:** Stryker Neurovascular
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-10
- **Report date:** 2020-04-08
- **Termination date:** 2021-02-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fremont, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1621-2020

## Citation

> AI Analytics. FDA recall Z-1621-2020. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1621-2020. Source: US FDA. Licensed CC0.

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