Device recall
Z-2614-2023: Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant…
FDA device recall · Class II · Abbott Medical
Key facts
| Recall number (Z-number) | Z-2614-2023 |
|---|---|
| Recall event | 92923 |
| Product | Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator: NxT DR ICD REF CDDRA600Q… |
| Product code | LWS |
| Recalling firm | Abbott Medical |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P910023, P910023S423 |
| FEI number | 2017865 |
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