Device recall
Z-2615-2023: Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF…
FDA device recall · Class II · Abbott Medical
Key facts
| Recall number (Z-number) | Z-2615-2023 |
|---|---|
| Recall event | 92923 |
| Product | Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchronization Therapy Defibrillator : HF CRT-D REF CDHFA300Q The primary function of ICDs and CRT-Ds are… |
| Product code | NIK |
| Recalling firm | Abbott Medical |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P030054, P030054S374 |
| 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