Device recall
Z-1172-2009: Medtronic RV Lead Integrity Alert, Cat. # SW012, 1.0 software in EnTrust(R)…
FDA device recall · Class III · Medtronic Inc. Cardiac Rhythm Managment
Key facts
| Recall number (Z-number) | Z-1172-2009 |
|---|---|
| Recall event | 51135 |
| Product | Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators. |
| Product code | LWS |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Managment |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 10, 2012 |
| PMA numbers | P010031, P010031S104, P980016, P980016S135 |
| 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