Medtronic has recalled the Harmony delivery catheter, part of the Harmony Transcatheter Pulmonary Valve (TPV) System, because the bond holding the capsule at the end of the delivery catheter may break during a procedure to place the valve.
“A capsule bond break could cause procedure delays while the device is replaced with a new one or it may require the patient to undergo additional surgeries,” according to the recall notice on the US Food and Drug Administration (FDA) website.
A capsule bond break that happens during a procedure could cause serious harm to the patient, including embolization or occlusion, perforation or dissection, or other types of damage to blood vessels.
The FDA has classified this as a class I recall, the most serious type, because of the potential for serious injury or death.
To date, there have been six reported complaints from clinical cases, one injury, and no deaths associated with the use of these devices.
The FDA approved Harmony TPV System in March 2021. The system is used to treat severe pulmonary regurgitation in pediatric and adult patients who have a native or surgically repaired right ventricular outflow tract.
A total of 665 Harmony TPV System delivery catheters have been recalled in the US. They were distributed between April 7, 2021, and January 26, 2022. Product codes and batch numbers are available on the FDA website.
On April 6, 2022, Medtronic issued an urgent medical device recall notice recommending that physicians remove all unused products and return them to Medtronic and pause new clinical cases involving the Harmony TPV System.
The FDA says it’s important to note that the break has only occurred in the delivery catheter during delivery of a TPV. No actions are needed for patients who have already been successfully implanted with a Harmony TPV, the FDA says.
Customers with questions or concerns about this recall should contact Medtronic Customer Service at 800-854-3570.
Healthcare professionals and consumers can report adverse reactions or quality problems they experience using the devices to the FDA’s MedWatch program.