Device recall
Z-0552-2025: Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150…
FDA device recall · Class III · Abbott Medical
Key facts
| Recall number (Z-number) | Z-0552-2025 |
|---|---|
| Recall event | 95557 |
| Product | Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will… |
| Product code | NVZ |
| Recalling firm | Abbott Medical |
| Recall class | Class III |
| Status | Open, Classified |
| PMA numbers | P910023, P910023S179 |
| FEI number | 2017865 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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