Device recall
Z-2416-2018: Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with…
FDA device recall · Class II · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Key facts
| Recall number (Z-number) | Z-2416-2018 |
|---|---|
| Recall event | 80379 |
| Product | Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias… |
| Product code | LWS |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2021 |
| PMA numbers | P980016 |
| 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