Merlin@home Transmitter REF EX1100 The Merlin@home" — Class III medical device recall Z-0551-2025
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-0551-2025 |
|---|---|
| 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 |
| Quantity | 130 transmitters |
| Reason classes | software |
| Serial numbers | 12600224, 12600307, 12600895, 12600974, 12601074, 12601156, 12601169, 12602176, 12602216, 12602464, 12602491, 12604265, 12604852, 12606254, 12606332, 12606531, 12606550, 12606551, 12606587, 12606785, 12606814, 12607289, 12607557, 12608093, 12608346 and 105 more |
| Model numbers | EX1100 |
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 device data and transmitting to the Merlin.net PCN server.
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-0551-2025. 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.