Device recall
Z-1069-2019: Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product…
FDA device recall · Class III · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Key facts
| Recall number (Z-number) | Z-1069-2019 |
|---|---|
| Recall event | 82319 |
| Product | Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation… |
| Product code | OAE |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Recall class | Class III |
| Status | Open, Classified |
| FEI number | 2182208 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database