Medtronic recalls heart valve delivery system due to safety risk
![Transcatheter pulmonary valve replacement (TPVR) with Medtronic’s self-expanding Harmony valve is both safe and effective after more than a year, according to new real-world data published in the Journal of the American College of Cardiology.[1]](/sites/default/files/styles/top_stories/public/2024-04/screen_shot_2024-04-04_at_3.49.33_pm_0.png.webp?itok=5SuKgFg7)
Medtronic is recalling certain lots of the delivery system for its Harmony Transcatheter Pulmonary Valve (TPV) System due to a significant safety risk. The U.S. Food and Drug Administration (FDA) has ruled this as a Class I recall, which means using the device could cause “serious adverse health consequences or death.”
Medtronic initiated the recall after identifying an issue with the delivery system that could lead to distal tip detachment during implant procedures. More than 1,800 devices are included in this Class I recall.
The Harmony TPV system is used to treat a native or surgically repaired right ventricular outflow tract (RVOT) in patients with severe pulmonary regurgitation. It has received FDA approval in addition to CE mark approval. Click here to read about a recent analysis of the device’s safety and effectiveness.
What should customers do?
Medtronic is urging customers to set aside any unused devices that are part of this recall and return them right away.
“Please share this notification with implanters and teams within your organization,” the company added.
Additional details are available here.
Medtronic experienced similar issues with the same device in 2022
Back in 2022, Medtronic recalled the Harmony TPV delivery catheter due to a risk of it breaking off and embolizing during use. The issue had been linked to six complaints and one patient injury.
Nearly one year later, after working closely with the FDA, Medtronic relaunched the Harmony TPV System.
“The relaunch of Harmony TPV underscores our continued commitment to advancing solutions for all people who experience heart disease, and we are proud to be driving innovation forward by offering the first non-surgical solution designed for congenital heart disease patients with severe pulmonary valve regurgitation,” Nina Goodheart, the president of Medtronic’s structural heart and aortic business, said at the time.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.