FDAJanuary 16, 2025device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
scientia vascularscientia
UPCs
00818075010479
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAArtegraft Vascular Graft; REF#: AG740;2026-02-10
- FDABroviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 600602025-12-12
- FDASafe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,2025-11-06
- FDAArtegraft¿ Collagen Vascular Graft; REF: AG1015;2025-09-25
- FDAArtegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;2025-09-02
- FDAArtegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.2025-08-25
- FDAVenclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically ...2025-08-21
- FDABrand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes ...2025-05-16
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