Device recall
Z-1191-2007: Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model…
FDA device recall · Class III · Boston Scientific Corp
Key facts
| Recall number (Z-number) | Z-1191-2007 |
|---|---|
| Recall event | 38351 |
| Product | Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0 |
| Product code | DRF |
| Recalling firm | Boston Scientific Corp |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 27, 2007 |
| 510(k) numbers | K924163 |
| FEI number | 3001236349 |
At a glance
- 1–9 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