Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150… — Class III medical device recall Z-0552-2025
Ongoing recall by Abbott Medical, reported 2024-12-04, distributed nationwide. Due to heart transmitter not being able to upgrade to the current software version in the field after experien
| Recall number | Z-0552-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical, Sylmar, CA, United States |
| Recall initiated | 2024-10-01 |
| Classified | 2024-11-26 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Reason classes | software |
| Model numbers | EX1150 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0552-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.