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

FDA device recall Z-1948-2026 · posted 2026-04-24 · Open, Classified

Recall details

Recalling firm

Medtronic, Inc.

Reason for recall

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.

Action taken

Medtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 3/18/2026 via USPS and email. The notice explained the issue and investigations and provided procedure recommendations: Arrhythmia and or VT/ VF is a known potential adverse event during a cardiac ablation procedure, as indicated within the Sphere-9 IFU. 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. As described in the Medtronic Sphere-9 IFU, defibrillation equipment must be available for immediate use in the case of a life-threatening arrhythmia. Further, the IFU recommends to not deliver energy when in contact with pacing and defibrillation leads. CUSTOMER ACTIONS: Follow the procedure recommendations listed in this letter in addition to the Instructions for Use (IFU) when using a Sphere-9 catheter with a concomitant Biotronik ICD/CRT-D. Complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. This form must be returned even if you do not have any affected product in your possession. Please forward this notice to all those who need to be aware within your organization, including, but not limited to, physicians using the Sphere-9 catheter, and maintain a copy for your records. *** Update: On 6/19/2026, Medtronic updated the field corrective action plan, including additional GTINs within scope, and a revised U.S. IFU

Root cause

Device Design

Status

Open, Classified

Product code

OAD

Quantity affected

120698 units

Distribution

Worldwide

Date initiated

2026-03-11

Date posted

2026-04-24

Location

Mounds View, MN