Merlin@Home Software Model EX2000 v8 — Class II medical device recall Z-0033-2018
Terminated recall by St Jude Medical Inc., reported 2017-10-25. New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers tha
| Recall number | Z-0033-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical Inc., Sylmar, CA, United States |
| Recall initiated | 2017-08-28 |
| Classified | 2017-10-19 |
| Reported by FDA | 2017-10-25 |
| Terminated | 2020-07-08 |
| Quantity | 495,011 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05414734404334, 05414734504782 |
| Model numbers | EX1100, EX1100W, EX1150, EX1150W, EX2000, V8.2.2 |
Product
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.
Reason for recall
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Machine access
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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.