St. Jude Medical Merlin@home Transmitter Software Reset Recall
St. Jude Medical is recalling Merlin@home RF Remote Monitoring Transmitters because a software reset may cause backup operation in implanted cardiac devices.
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 involves a medical device that may cause backup operation in implanted cardiac devices, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
St. Jude Medical Cardiac Rhythm Management Division is recalling the Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. The recall involves 257,456 units distributed worldwide, including the United States, the European Union, the Middle East, Canada, Australia/New Zealand, and the Asia-Pacific region.
The recall is issued because the transmitter may initiate a software reset, which can result 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. This issue affects patients using these specific implanted devices in conjunction with the recalled remote monitoring transmitters.
Consumers and healthcare providers should contact St. Jude Medical or their healthcare provider for instructions on how to address the potential software reset issue and ensure proper monitoring of the implanted devices.
The recalled product
- Product
- Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
- Affected units
- 257,456
Distribution
Distributed nationwide across the United States.
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