Medtronic issued a voluntary recall of 102 lots of its Harmony delivery catheter system due to a risk of the their tips detaching, which could result in serious injury or death.
The recall, which was posted on the FDA’s website, is classified by the agency as Class I, its most serious type. Medtronic began notifying customers in a May 28 letter.
The Harmony delivery catheter system was designed for single use with an intravascular, over-the-wire delivery catheter incorporating a loading system that is used for the placement of the Harmony transcatheter pulmonary valve (TPV).
“Certain lots of the Harmony DCS used for insertion of the Medtronic Harmony TPV have an increased risk of distal tip detachment,” the company said in its letter. “Detachment of the distal tip during the implant procedure will require a secondary intervention to remove the tip, either by endovascular retrieval or surgical intervention.”
Other risks include longer times in surgery, occlusion, tissue damage, pulmonary regurgitation, embolism and hemorrhage.
This problem does not involve the Harmony TPV, and patients successfully implanted with the system should continue to be monitored to appropriate follow-up procedures, Medtronic said.
As of May 14, the company had not received reports of any serious injuries or death related to the recall.
The action comes a little over a year after the medical device giant recalled its acid reflux testing system in the wake of 33 reports of serious injuries related to the device. That recall was initiated after it was found adhesives that were misapplied during manufacturing could cause the capsule to come loose during the procedure or not adhere correctly to the esophagus wall.