FDA classifies Medtronic catheter recall as Class I

Medtronic’s (NYSE:MDT) voluntary recall of its 6F Sherpa NX Active Coronary Guide Catheter is considered Class I by the FDA, its highest level since the product issue could cause serious injury or death.

Affected catheters have a risk of losing outer material from a distal component which could result in the underlying stainless steel braid wires being exposed after insertion, although the company says it has not received any reports of patient injuries to date. The company investigated the issue after receiving six complaints.

https://seekingalpha.com/news/3504832-fda-classifies-medtronic-catheter-recall-class