FDA recall, , Moderate risk
Medtronic Sphere-9 Catheter
The Sphere-9 Catheter can cause ventricular fibrillation during RF therapy in patients with certain Biotronik defibrillators.
Summary by Recall Canary from the FDA notice
What happened
Medtronic, Inc., of Mounds View, Minnesota, voluntarily recalled the Medtronic Sphere-9 Catheter, Model Number AFR-00001, on March 11, 2026.
The catheter, percutaneous, cardiac ablation, for treatment of atrial flutter, can cause 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.
The FDA added the recall to its Enforcement Report on April 24, 2026, and it was included in the weekly enforcement report on May 6, 2026. The recall was firm-initiated and distributed worldwide.
What to do
If a code on your device is listed below:
- 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.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medtronic Sphere-9 Catheter
- Model number
- AFR-00001
- UDI-DI
- 00763000871741
- 00763000973391
- 00763000973506
- 00763000993269
- 00199150003709
- 00763000871734
- 00763000973384
- 00763000973513
- 00763000811341
- 00763000911515
- 00763000963675
- 00199150003716
Recall details
- Company began the recall
- Sold in
Worldwide
- Company
- Medtronic, Inc.Mounds View, Minnesota
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98653
- Recall number
- Z-1948-2026
- Quantity recalled
- 120698 units
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
All recalls from Medtronic, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
