UPDATED August 7, 2015, with comment from Medtronic.
Medtronic (NYSE:MDT) is recalling some 6,900 EnVeo R loading systems for its CoreValve Evolut R replacement heart valve, after particulate matter turned up in some lots. The FDA gave the 6,912-unit recall Class I status, denoting a problem that could lead to serious injury or death.
Fridley, Minn.-based Medtronic issued an urgent field safety notice to customers who bought the affected EnVeo R devices, saying it’s recalling them “due to particulate being observed in a small number of cases.”
“Through 6 July 2015, Medtronic has received eight (8) reports related to this issue out of 7,347 potentially affected units. Two (2) were reported as particulate being observed in packaged kits and six (6) were reported as particulate being observed in the loading bath during valve loading. To date, there have been no reports of any adverse patient effects with this issue [emphasis theirs]. This issue does not affect other Medtronic devices or other components of the Evolut R TAV system,” Medtronic said, noting that the particulate could be transferred to the transcatheter aortic valve implant and released into the vasculature after deployment.
“If this were to occur, potential harms may include embolism into the bloodstream. While Medtronic has received only 8 reports of particulate identified from the loading system, with no reports of adverse patient effects, bench testing has demonstrated a higher prevalence of particulate and the potential for its transfer to the TAV,” the company said.
Medtronic spokeswoman Wendy Dougherty told MassDevice.com via email that all of the EnVeo R devices affected by the recall have already been removed from the market. None of the affected units were released commercially in the U.S., Daugherty added.
“The issue has already been resolved with the introduction of a process improvement in manufacturing,” she wrote.