Merlin@home RF Remote Monitoring Transmitter — Class II medical device recall Z-0949-2015
Terminated recall by St Jude Medical Cardiac Rhythm Management Division, reported 2015-01-21, distributed nationwide. Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Rad
| Recall number | Z-0949-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical Cardiac Rhythm Management Division, Sylmar, CA, United States |
| Recall initiated | 2014-12-18 |
| Classified | 2015-01-09 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2016-03-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, JP, NZ |
| Quantity | 257,456 units |
| Reason classes | software |
| Serial numbers | 12200972, 12201054, 12201068, 12201270, 12201533, 12201550, 12201617, 12201625, 12201684, 12201700, 12201701, 12202350, 12202580, 12202588, 12202600, 12203035, 12203167, 12204274, 12204499, 12204527, 12204991, 12205977, 12207623, 12208935, 12210354 and 475 more |
| Model numbers | EX1150 |
Product
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Reason for recall
Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.
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-0949-2015. 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.