Recall Z-1235-2025 ยท QJP Catheter, Percutaneous, Neurovasculature
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.
| Date | Feb 26, 2025 (initiated Jan 16, 2025) |
| Status | Open, Classified |
| 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 a |
| Quantity | 1 unit |
| Distribution | U.S. Nationwide distribution in the state of DE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223560 | Plato 17 Microcatheter Scientia Vascular, Inc., Aug 21, 2023 |