St. Jude Medical Recalls Merlin@Home Software for Pacemaker Security
St. Jude Medical is recalling Merlin@Home software to mitigate the risk of unauthorized access to pacemakers using radio frequency communications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall addresses a security vulnerability in a medical device that could lead to unauthorized access, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
St. Jude Medical Inc. is recalling Merlin@Home Software Model EX2000 v8.2.2 for use with Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. These transmitters are components of the St. Jude Medical Remote Care System, which retrieves information from implantable medical devices using radio frequency telemetry to allow clinicians to monitor patients remotely.
The recall is being conducted because new pacemaker firmware was developed to further mitigate the risk of unauthorized access to pacemakers that utilize radio frequency communications. The software is used to transmit data from the patient's device to the Merlin.net Patient Care Network, enabling remote monitoring and reducing the need for in-clinic visits.
Approximately 495,011 units were distributed worldwide, with 391,093 units in the United States. Affected users should contact St. Jude Medical for instructions on obtaining the updated firmware to secure their devices against potential unauthorized access.
The recalled product
- 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…
- Manufacturer
- St Jude Medical Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model EX1100 - GTIN 05414734504782 and Model EX1150 - GTIN 05414734404334
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 10 recalled by St Jude Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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