Device recall
Z-2371-2020: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO…
FDA device recall · Class II · BIOSENSE WEBSTER
Key facts
| Recall number (Z-number) | Z-2371-2020 |
|---|---|
| Recall event | 85559 |
| Product | PENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only… |
| Product code | MTD |
| Recalling firm | BIOSENSE WEBSTER |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2022 |
| 510(k) numbers | K120425 |
| FEI number | 3013300026 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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