Medtronic, Inc.: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Recalling firm

Medtronic, Inc.

Product

Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.

Reason

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 interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external...

Classification

Class III

Category

medical device recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-03-11

Status

Open, Classified

Distribution

Worldwide

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/3a9eed36-150a-4c29-8b02-32b95c1f2cae