- Medtronic Plc (NYSE:MDT) is recalling the Harmony Delivery Catheter, part of the Transcatheter Pulmonary Valve (TPV), due to the possibility that the bond holding the capsule at the end of the delivery catheter may break during a procedure.
- Harmony TPV System is used to treat a leaky native or surgically repaired right ventricular outflow tract (RVOT), a part of the heart that carries blood to the lungs.
- The Harmony TPV System consists of a transcatheter pulmonary valve and a delivery catheter to implant the replacement valve without open-heart surgery.
- Also See: Medtronic Issues Voluntary Recall For TurboHawk Plus Directional Atherectomy System.
- The system is indicated for use in severe pulmonary regurgitation. The blood flows backward from the RVOT into the right lower chamber (right ventricle) of the heart and requires pulmonary valve replacement.
- A capsule bond break could cause procedure delays or require the patient to undergo additional surgeries.
- Additionally, a capsule bond break could cause serious harm to the patient, including embolization or occlusion, tearing/splitting, or other types of damage to the patient’s blood vessels.
- There have been six reported complaints from clinical cases, one injury, and no deaths associated with these devices.
- 665 catheters are affected distributed between April 2021 - January 2022.
- Price Action: MDT shares are down 0.67% at $108.74 during the market session on the last check Tuesday.
