Device recall
Z-2444-2010: St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator The PACE…
FDA device recall · Class II · Osypka Medical Inc
Key facts
| Recall number (Z-number) | Z-2444-2010 |
|---|---|
| Recall event | 56121 |
| Product | St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203H / Model 3085 has… |
| Product code | DTE |
| Recalling firm | Osypka Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 10, 2012 |
| 510(k) numbers | K020896 |
| FEI number | 3004185614 |
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