Heart Device Transmitter Fails to Update Software After Power Interruption
Abbott Medical's Merlin@home transmitter cannot upgrade to current software after power interruptions during prior downloads. This affects remote heart device monitoring systems.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is classified as a Class III recall, the FDA's lowest classification. While the software upgrade failure could affect long-term device management, no illnesses or injuries have been reported, and devices can continue to function with existing software.
Plain-English summary
Abbott Medical is recalling the Merlin@home with MerlinOnDemand capability Transmitter (Model EX1150), a remote monitoring device that receives information from implantable heart devices and communicates with the Merlin.net Patient Care Network. Clinicians use this device to support remote patient care, triage patients, and enable emergency room and heart failure clinic monitoring.
The transmitter cannot upgrade to the current software version after a power interruption occurs during an over-the-wire software download. This can leave affected units running outdated software.
The recall affects units distributed nationwide in 28 U.S. states (Alabama, Alaska, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan, Mississippi, Missouri, Montana, Nebraska, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and Wisconsin) and in Australia. The FDA has classified this as a Class III recall. No illnesses or injuries related to this issue have been reported.
The recalled product
- Product
- Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability
- Manufacturer
- Abbott Medical
- 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 Number: EX1150 UDI-DI code: Pending Serial Numbers: Pending
Distribution
Part of a larger recall action
This product is one of 2 recalled by Abbott Medical 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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