Recall archive / FDA device enforcement
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090 — FDA record Z-1249-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
- 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.
- Classification
- Class II
- Recalling firm
- Scientia Vascular, Inc.
- Quantity
- 353
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1249-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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) |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 22, 2023
- Recall initiation date
- Feb 1, 2023
- Center classification date
- Mar 13, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.