Medtronic’s BioGlide catheter issued class I recall
This article was originally published in Clinica
Executive Summary
The US FDA has given Medtronic’s voluntary recall of its BioGlide ventricular snap shunt catheter a class I classification. The recall, which was initiated by the company in February, was triggered by nine reports of disconnected catheters that required revision surgery. In its recall notice, the FDA said that the action applied to 3,000 BioGlide catheters in the US, Ireland and Australia, and, as of March 18, Medtronic had completed contact with all users of the devices. The FDA said that there have been no reports of serious patient injury or death because of the faults.