Device recall
Z-1284-2015: TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF)…
FDA device recall · Class II · St Jude Medical
Key facts
| Recall number (Z-number) | Z-1284-2015 |
|---|---|
| Recall event | 70490 |
| Product | TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use in cardiac… |
| Product code | OAE |
| Recalling firm | St Jude Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 6, 2015 |
| PMA numbers | P130026 |
| FEI number | 3007562768 |
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