Device recall
Z-0551-2025: Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is…
FDA device recall · Class III · Abbott Medical
Key facts
| Recall number (Z-number) | Z-0551-2025 |
|---|---|
| Recall event | 95557 |
| Product | Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read… |
| Product code | NVZ |
| Recalling firm | Abbott Medical |
| Recall class | Class III |
| Status | Open, Classified |
| PMA numbers | P910023, P910023S191 |
| 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