FDA recall Z-1249-2023

Product

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

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.

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.

Key facts

Status

Ongoing

Initiation date

2023-02-01

Report date

2023-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Valley City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1249-2023