Recall archive / FDA device enforcement
Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and i... — FDA record Z-1235-2025
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 Jan 16, 2025. 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 REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
- Reason
- Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
- Classification
- Class II
- Recalling firm
- Scientia Vascular, Inc.
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1235-2025
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 | Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. Nationwide distribution in the state of DE.
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 5, 2025
- Recall initiation date
- Jan 16, 2025
- Center classification date
- Feb 26, 2025
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.