Dive Brief:
- Medtronic is removing from the market certain lots of a catheter used to place pulmonary valves, the Food and Drug Administration said in a Monday recall notice.
- The affected devices have an increased risk that the distal tip may detach from the delivery catheter system, requiring another procedure to remove the tip. As of May 14, Medtronic had not reported any serious injuries or deaths associated with the issue, according to the FDA notice.
- A Medtronic spokesperson said in an emailed statement to MedTech Dive that the problem is limited to certain delivery systems and does not involve the valve itself. Medtronic has resolved the underlying manufacturing problem, so future shipments will not be affected by the recall, the spokesperson wrote.
Dive Insight:
Medtronic’s affected catheters are used to place a heart valve. The Harmony transcatheter pulmonary valve is indicated for adults and children with severe pulmonary regurgitation, a condition where the heart’s pulmonary valve fails to close completely.
People who have already received a Harmony valve are not affected by the recall, the Medtronic spokesperson wrote.
Medtronic sent a letter to customers in May instructing them to immediately quarantine and return the affected lots of delivery catheter systems.
If the distal tip is detached, endovascular retrieval or surgical intervention may be required to remove it. Other risks include prolonged procedure time, extended fluoroscopy time, tissue damage, embolism and hemorrhage, according to the FDA notice.
The action included more than 1,800 units distributed worldwide, according to an FDA enforcement report. The FDA categorized the recall as Class I, its highest risk level.
