Recall Z-1621-2020 ยท NRY Catheter, Thrombus Retriever
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
| Date | Apr 10, 2019 |
| Status | Terminated |
| 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 shaf |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181354 | 074 Zenith Flex System Inneuroco, Inc., Oct 25, 2018 |