Medtronic, Inc. — Class II recall: Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, car…

Summary

ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interact… Status: Ongoing.

Entities

• Medtronic, Inc.