FDA Device recall Z-0552-2025
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitte…
- FDA Device
- Class III
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class III recall of Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitte… by Abbott Medical, citing due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software downl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0552-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-10-01 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Medical |
| Distribution | US |
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 retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN
Reason
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
Identifiers
| code_info | Model Number: EX1150 UDI-DI code: Pending Serial Numbers: Pending |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0552-2025%22
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