FDA Medical devices recall ·
Plato 17 Microcatheter recall
- Recall number
- Z-1235-2025
- Date
- (initiated January 16, 2025)
- Company / brand
- Scientia Vascular, Inc.
2460 S 3270 W, West Valley City, UT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300
Distribution
U.S. Nationwide distribution in the state of DE.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1235-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.