Device recall
Z-0169-2023: THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S…
FDA device recall · Class II · Johnson & Johnson Surgical Vision, Inc.
Key facts
| Recall number (Z-number) | Z-0169-2023 |
|---|---|
| Recall event | 90887 |
| Product | THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation. |
| Product code | OAD |
| Recalling firm | Johnson & Johnson Surgical Vision, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P030031 |
| FEI number | 3012236936 |
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