Z-1249-2023 Class II Ongoing
FDA device recall Z-1249-2023 was initiated by Scientia Vascular, Inc. on February 1, 2023 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 353.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2023
- Initiation Date
- February 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 353
Product Description
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 Pattern
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.
Code Information
All lots, REF/UDI-DI/Lot(Expiration): PL17-160-000/00818075010455/ 900164(8/31/2022), 900165(8/31/2022), 900172(8/31/2022), 900177(9/30/2022), 900180(9/30/2022), 900186(10/31/2022), 900187(10/31/2022), 900188(10/31/2022), 900193(10/31/2022), 900196(12/31/2022), 900199(12/31/2022), 900202(12/31/2022), 900221(2/28/2023), 900222(2/28/2023), 900225(2/28/2023), 900226(3/31/2023), 20441(11/30/2023), 20476(11/30/2023), 20650(12/31/2023); PL17-160-045/00818075010462/900167(8/31/2022), 900168(8/31/2022), 900169(8/31/2022), 900174(8/31/2022), 900175(8/31/2022), 900179(9/30/2022), 900181(9/30/2022), 900183(10/31/2022), 900185(10/31/2022), 900205(1/31/2023), 900206(1/31/2023), 900210(1/31/2023), 900211(1/31/2023), 900215(1/31/2023), 900220(1/31/2023), 900219(1/31/2023), 900217(2/28/2023), 900223(2/28/2023), 900224(2/28/2023); PL17-160-090/00818075010479/900170(8/31/2022), 900171(8/31/2022), 900178(9/30/2022), 900182(9/30/2022), 900184(10/31/2022), 900192(11/30/2022), 900195(11/30/2022), 900209(1/31/2023), 900228(3/31/2023)