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.
Scientia Vascular
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.
Class I - Dangerous
Microcatheters for embolic coil and diagnostic agent introduction to peripheral/neuro vasculature, due to manufacturing non-conformance, and due to flush, guidewire insertion and manipulation prior to placement, may have loose particles within catheter lumens that may be introduced to patients, which could cause embolic event, small vessel occlusion, and subacute to chronic inflammatory response.