Plato 17 Microcatheter (Scientia) – packaging seal breach (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Scientia Vascular, Inc.
Lot Codes / Batch Numbers
Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300
Products Sold
Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300
Scientia Vascular, Inc. is recalling Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolizati due to 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 i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 customercare@scientiavascular.com or (888)385-9016; Monday through Friday, 8:00 AM to 4:30 PM, Mountain Time.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026