Scientia Vascular, Inc. recalls Socrates 38 Aspiration Catheter 127 cm length REF SC038-127
Recalled Product
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
Hazard / Issue
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.
Issued by
FDA
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