Z-1235-2025Class II

Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization...

Name: Z-1235-2025 Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization...
Creator: Scientia Vascular, Inc.
Published: 2025-01-16
License: https://open.fda.gov/license/

Scientia Vascular / initiated 2025-01-16 / Open, Classified / root cause: packaging

FDA source

Scientia Vascular, Inc. began a recall of 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... on 2025-01-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1235-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-16
Posted: 2025-02-26
Recalling firm: Scientia Vascular
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.
Product code: QJP Catheter, Percutaneous, Neurovasculature
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.
Root cause tag: packaging
FDA root cause: Under Investigation by 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.
Quantity in commerce: 1 unit
Distribution: U.S. Nationwide distribution in the state of DE.
Product codes and lots: Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1235-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1235-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-05	2025-02-26

Product code QJP

K223560Class IIPlato 17 MicrocatheterScientia Vascular, Inc. / cleared 2023-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)