St Jude Merlin@home Transmitter Recalled for Backup VVI Operation
St Jude Medical is recalling Merlin@home RF Remote Monitoring Transmitters because some devices exhibit backup VVI operation due to a backup reset.
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 with a functional defect (backup VVI operation) that poses a risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
St Jude Medical Cardiac Rhythm Management Division is recalling the Merlin@home RF Remote Monitoring Transmitter, Model EX1150. This device is intended to aid in the remote support of St Jude Medical implantable pacemakers and ICDs.
The recall is being issued because some devices exhibit backup VVI operation due to a backup reset. The source text does not specify the number of affected units, the specific dates of distribution, or whether any injuries or illnesses have been reported.
Affected units were distributed worldwide, including nationwide in the United States and to various foreign countries. Consumers with this device should contact St Jude Medical for further instructions on how to proceed.
The recalled product
- Product
- Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
Distribution
Distributed nationwide across the United States.
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