Device recall
Z-0474-2011: Medtronic Sprint Quattro Secure S, model 6935. Steroid eluting, tripolar…
FDA device recall · Class II · Medtronic Inc. Cardiac Rhythm Disease Managment
Key facts
| Recall number (Z-number) | Z-0474-2011 |
|---|---|
| Recall event | 57090 |
| Product | Medtronic Sprint Quattro Secure S, model 6935. Steroid eluting, tripolar, screw-in, ventricular lead with RV defibrillation coil electrode. Contents Sterile. Manufactured in: Villalba, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 U.S.A. |
| Product code | LWS |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Managment |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 4, 2012 |
| PMA numbers | P920015, P920015S039 |
| 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