Device recall
Z-0699-2019: Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated…
FDA device recall · Class III · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0699-2019 |
|---|---|
| Recall event | 81747 |
| Product | Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or… |
| Product code | OAD |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class III |
| Status | Open, Classified |
| PMA numbers | P150005 |
| FEI number | 3004859241 |
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