Device recall
Z-1607-2013: Medtronic, Consulta CRT-P, Model C4TR01, C3TR01 (not approved for US), and…
FDA device recall · Class II · Medtronic Inc. Cardiac Rhythm Disease Management
Key facts
| Recall number (Z-number) | Z-1607-2013 |
|---|---|
| Recall event | 65433 |
| Product | Medtronic, Consulta CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony. |
| Product code | NKE |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 7, 2014 |
| PMA numbers | P010015, P010015S084 |
| FEI number | 2182208 |
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