BioGlide recall
This article was originally published in The Gray Sheet
Executive Summary
Ongoing recall of three models of Medtronic BioGlide ventricular snap shunt catheters for hydrocephalus treatment, initiated by the firm in February, is determined to be Class I by FDA. Based on nine reports, Medtronic determined the catheter may become detached from the snap base assembly after implantation, potentially requiring emergency corrective surgery. About 3,000 of the catheters were distributed between 2002 and 2009