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.
FDA Recall Z-1235-2025 · Posted 2025-02-26
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Recalling FirmScientia Vascular, Inc.
Recall StatusOpen, Classified
Product CodeQJP
Date Initiated2025-01-16
Product Quantity1 unit
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.
Firm Action
On 01/02/2025, the firm email an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that through internal evaluation of finished goods of the Plato 17 Microcatheter, one lot of pouches containing the 90 Tip Plato 17 Microcatheter was identified with pouches that had a gap in the sterile barrier seal.
Customer are instructed to:
In situations where a device has already been used in a patient procedure, closely monitor patients for signs and symptoms of post-surgical infection.
Customer Service will be available to provide additional information and provide replacement orders at [email protected] or (888)385-9016; Monday through Friday, 8:00 AM to 4:30 PM, Mountain Time.
Root Cause
Under Investigation by firm
Distribution Pattern
U.S. Nationwide distribution in the state of DE.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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