FDA product code QZI: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
QZI is the FDA product code for percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation. It is a Class III device, reviewed by the Cardiovascular panel. Devices under QZI reach the market by PMA; FDA lists no cleared 510(k)s for it. 6 PMA applications cite this product code. FDA has posted 2 recalls for QZI devices, 2 initiated in the last five years.
Definition
For the treatment of atrial fibrillation.
Classification
| Field | Value |
|---|---|
| Device name | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QZI devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-06-25.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code QZI?
QZI is the FDA product code for percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is QZI?
Class III. Typical premarket route: PMA.
Have QZI devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-06-25.
Next steps
- Run an FDA pathway report with predicate devices for product code QZI
- Run a recall and safety report across every QZI manufacturer
- Watch product code QZI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.