Medtronic EnVeo Heart Device Recall Issued Over Particulate Matter

Medtronic is recalling about 7,000 loading devices for a heart valve replacement system, following reports that suggest they may contain particulate matter that could get into a patient’s bloodstream. 

An Medtronic EnVeo R Loading System recall was announced by the FDA on August 5, after the manufacturer received at least eight reports of particulate matter being observed both in package kits and in the loading bath during valve loading. No injuries or adverse events have been reported.

The Enveo R Loading System is part of a transaortic valve replacement system known as the CoreValve Evolut R system. It is used in patients with narrow aortic valves, known as severe aortic stenosis, for whom surgery is too risky.

Medtronic warns that the device could transfer the observed particulate matter into the patient’s vasculature, which could cause an embolism.

In a letter sent to health care professionals last month, Medtronic said that testing has demonstrated that the risk is real.

The recall affects 6,912 of the EnVeo R Loading System, model numbers. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, and LS-EnVeoR-2629-C; 540 of which were sold in the United States. A complete list of affected lot numbers is available in the FDA recall notice and in the Medtronic letter. An estimated 540 of the units were sold in the United States.

The FDA has classified this as a class 1 recall, meaning the agency believes the particulate matter could cause severe injury or death in patients where it is used. It is the agency’s highest and most severe recall classification.

Medtronic has requested that health care and risk management professionals at facilities that have the recalled devices immediately quarantine any unused products from their inventory and return affected products to Medtronic.