# P240013: Sphere-9 Catheter and Affera Ablation System

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Oct 24, 2024 after 196 days
- Product code: QZI (Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Mar 11, 2026 · Class II · Z-1948-2026: 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 Biotroni

Source page: https://510kreport.com/device/P240013
Methodology: https://510kreport.com/methodology