Recall Z-1249-2023 ยท DQY Catheter, Percutaneous
Scientia Vascular, Inc.
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
| Date | Mar 13, 2023 (initiated Feb 1, 2023) |
| Status | Open, Classified |
| Reason | Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush, guidewire insertion and manipulation prior to placement, may have loose particles within catheter lumens that may be introduced to patients, which could cause embolic event, small vessel occlusion, and subacute to chronic inflammatory response. |
| Root cause | Device Design |
| Action | On 02/01/23, recall notices were mailed and emailed to customers who were told the following: Actions for Customer/User: Identify and segregate affected devices. Actions for Recalling Firm: Sales representatives will visit and assist with completing the acknowledgement and receipt form and the collection of affected devices. If devices have been transferred from one facility to another the additional consignees will be contacted upon identification. Sales reps received the recall notice and a response form they would take to customers to obtain additional information and the affected devic |
| Quantity | 353 |
| Distribution | US Nationwide distribution in the states of IL, AL, FL, NC, WI, GA, SC, IN, KS, CA, OH, NY, NH, CO, MA, NV, UT, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210601 | Plato 17 Microcatheter Scientia Vascular, LLC, Apr 28, 2021 |