FDA Medical Device Recalls (openFDA)
Scientia Vascular, Inc.: 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.
- Recall number
- Z-1235-2025
- Recalling firm
- Scientia Vascular, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2025-01-16
- Posted
- 2025-02-26
- Terminated
- not on file
- Reason
- 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
- 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 customercare@scientiavascular.com or (888)385-9016; Monday through Friday, 8:00 AM to 4:30 PM, Mountain Time.
- Quantity
- 1 unit
- Distribution
- U.S. Nationwide distribution in the state of DE.
- Lot, serial or model codes
- Catalog Number: PL17-160-090 UDI-DI code: 00818075010479 Lot Number: 031300
- 510(k) numbers
- ["K223560"]
- PMA numbers
- not on file
- Product code
- QJP
- Firm FEI
- 3009546466
- Firm city
- West Valley City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28