Device recall
Z-2650-2016: Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product…
FDA device recall · Class II · Medtronic Inc., Cardiac Rhythm and Heart Failure
Key facts
| Recall number (Z-number) | Z-2650-2016 |
|---|---|
| Recall event | 74923 |
| Product | Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT -D) is a… |
| Product code | LWS |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 20, 2017 |
| PMA numbers | P010031, P010031S318 |
| 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