Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150 Recalled by St Jude Medical Inc. Due to New pacemaker firmware was developed to further mitigate...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact St Jude Medical Inc. directly.
Affected Products
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.
Quantity: 495,011 units (391,093 in US)
Why Was This Recalled?
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Where Was This Sold?
Worldwide Distribution
About St Jude Medical Inc.
St Jude Medical Inc. has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report