Recall Z-2299-2020 ยท DXE Catheter, Embolectomy
INARI MEDICAL
Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
| Date | Mar 23, 2020 |
| Status | Terminated |
| Reason | The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device must be used or suboptimal thrombus removal if the problem is not detected. |
| Root cause | Equipment maintenance |
| Action | On 03/23/20, Urgent Medical Device Recall notices were emailed to customers. Customers were asked to take the following actions: 1.Immediately review your inventory for the affected devices and quarantined to prevent their use. 2.Complete and return the Customer Response Form. 3.Return quarantined devices to recalling firm. 4.Report any adverse health consequences experienced with the use of this product to the recalling firm. Customers with additional questions were encouraged to contact the firm at: 877.923.4747 or customerservice@inarimedical.com Additional recall notices with an expande |
| Quantity | 318 |
| Distribution | U.S Distribution in the states of .: IA, GA, MO, MI, AZ, FL, NJ, MN, LA, PA, AL, OH, NY, WI, CA, TX, TN, NH, IL, NC, CT, CO, OK, OR, IN, MA, VA, KY, WA, MS, SC, UT, SD, ND, AR, ID, DE, including DC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182233 | FlowTriever Retrieval/Aspiration System Inari Medical, Oct 15, 2018 |