HIGH
FDA DEVICE
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Medtronic
ventricular fibrillation
Brand hub
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.