Recall Z-1235-2025— Scientia Vascular, Inc.
Class II · Ongoing
Class II FDA medical device recall by Scientia Vascular, Inc., initiated 2025-01-16. It names one FDA 510(k) clearance: K223560. 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..
- Recalling firm
- Scientia Vascular, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-16
- Firm location
- West Valley City, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.