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Scientia Vascular, Inc. FDA Recalls
3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and iClass IIJan 16, 2025Due to manufacturing non-conformance that resulted in channe |
| Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible sucClass IIJan 2, 2025Due to manufacturing non-conformance that resulted in channe |
| Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090Class IIFeb 1, 2023Microcatheters for embolic coil and diagnostic agent introdu |