Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090

FDA device recall Z-1249-2023 · posted 2023-03-13 · Open, Classified

Recall details

Recalling firm

Scientia Vascular, Inc.

Reason for recall

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.

Action taken

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 devices. Customers with questions can contact customer support at 1-888-385-9016 9016 between the hours of 9:30 AM and 6:30 PM ET (7:30 AM and 4:30 PM MST), Monday through Friday, or via email to regulatory@scientiavascular.com

Root cause

Device Design

Status

Open, Classified

Product code

DQY

Quantity affected

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.

Date initiated

2023-02-01

Date posted

2023-03-13

Location

West Valley City, UT

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