Plato recallZ-1235-2025 · Scientia Vascular, Inc. · initiated Jan 16, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Scientia Vascular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1235-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 16, 2025
- Posted by the FDA
- Feb 26, 2025
- Recalling firm
- Scientia Vascular, Inc.
- Quantity
- 1 unit
- Product code
- QJP
- FDA submissions
- K223560
- Distribution
- U.S. Nationwide distribution in the state of DE.
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.
Code information (models, lots, serial numbers)
Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Plato 17-160-090Scientia Vascular LLC · Catheter, Percutaneous2 recalls0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K223560 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Plato 17-160-000Scientia Vascular LLC · Catheter, Percutaneous1 recall3 reports
- Plato 17-160-045Scientia Vascular LLC · Catheter, Percutaneous1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page