Medtronic recalls Sphere-9 catheters (model AFR-00001) for patients with Biotronik ICDs or CRT-Ds due to risk of ventricular fibrillation during radiofrequency therapy. Medtronic recommends increased caution and availability of external defibrillation systems.
Ventricular fibrillation (VF) occurred 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.
Medtronic is recalling a specific model of cardiac catheter (Sphere-9, model AFR-00001) because it can cause ventricular fibrillation when used with certain heart devices (Biotronik ICDs or CRT-Ds). This interaction happens during radiofrequency therapy. Patients with these devices should be cautious and ensure external defibrillation equipment is ready.
The Sphere-9 catheter's electrical current flow can interact with a safety feature in Biotronik ICDs and CRT-Ds, causing ventricular fibrillation (a life-threatening heart rhythm). This interaction occurs during radiofrequency therapy for atrial flutter treatment.
Patients with a Biotronik Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) who have the recalled Sphere-9 catheter. The risk is during radiofrequency ablation therapy.
Check if your catheter has the model number AFR-00001. The recall includes specific serial numbers and GTINs listed in the official notice. If you have a Biotronik ICD or CRT-D, contact Medtronic for verification.
Reach out to Medtronic directly to confirm if your catheter is affected and get guidance on next steps.
No, the recall only applies to patients with Biotronik ICDs or CRT-Ds. If you don't have these devices, the catheter is not affected by this hazard.
No, the recall does not require immediate discontinuation. Medtronic recommends increased caution during therapy and ensuring external defibrillation equipment is available.
Check the model number on your catheter (AFR-00001) and compare it to the list of serial numbers and GTINs provided in the official recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1948-2026 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1948-2026 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
