Medtronic Recalls Harmony Catheter System Over Detachment Risk, FDA Announces

The FDA has announced a recall by Medtronic for specific lots of its Harmony Delivery Catheter System. This recall is due to a potential risk of the device's distal tip detaching, which could pose a serious safety concern for patients. The system is used to insert a transcatheter pulmonary valve, making this a critical safety alert for healthcare providers and patients.