Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infu
FDA device recall Z-1235-2025 · posted 2025-02-26 · Open, Classified
Recall details
- Recalling firm
- Scientia Vascular, Inc.
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- QJP
- Quantity affected
- 1 unit
- Distribution
- U.S. Nationwide distribution in the state of DE.
- Date initiated
- 2025-01-16
- Date posted
- 2025-02-26
- Location
- West Valley City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Plato 17 Microcatheter (K223560) | Scientia Vascular, Inc. | 2023-08-21 |