Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac… Recall
Issued May 6, 2026 · Medtronic, Inc.
In May 2026, Medtronic, Inc. recalled the Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 defibrillation systems are readily available.
What you should do
- 1 Stop using Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medtronic, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Medtronic, Inc.
- Category
- Health
- Recall date
- May 6, 2026
- Units affected
- Not reported
- Sold at
- Worldwide
- Recall number
- FDA-Z-1948-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Medtronic, Inc. has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.