Recall Z-1235-2025
Scientia Vascular, Inc. · initiated January 16, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1235-2025
- Initiated
- January 16, 2025
- Posted by FDA
- February 26, 2025
- Product code
- QJP – Catheter, Percutaneous, Neurovasculature
- Quantity
- 1 unit
- Distribution
- U.S. Nationwide distribution in the state of DE.
- Recalling firm
- Scientia Vascular, Inc., West Valley City, UT