Device recall
Z-0068-2008: Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular…
FDA device recall · Class I · Medtronic Inc. Cardiac Rhythm Managment
Key facts
| Recall number (Z-number) | Z-0068-2008 |
|---|---|
| Recall event | 45403 |
| Product | Medtronic Sprint Fidelis 6931 Steroid eluting, tripolar, screw-in, ventricular lead with right ventricular (RV) defibrillation coil electrode. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies. Medtronic World Headquarters, Medtronic, Inc., 710 Medtronic… |
| Product code | LWS |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Managment |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 21, 2011 |
| PMA numbers | P920015 |
| FEI number | 2182208 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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