Abbott Merlin@home Cardiac Monitoring Transmitters Fail to Update After Power Loss
Abbott is recalling 130 Merlin@home cardiac transmitters that cannot update software after power interruption during firmware download. Affected devices remain on outdated firmware with no ability to receive future updates.
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: FDA Class III medical device with a functional software update defect. No reported adverse health events. The recall is precautionary due to inability to receive software updates after power interruption.
Plain-English summary
Abbott is recalling 130 Merlin@home Transmitters (model EX1100), devices used for remote monitoring of implanted cardiac devices. The transmitter transfers data from implanted cardiac devices to the Merlin.net Patient Care Network for physician monitoring.
Following a power interruption during a software download, affected transmitters cannot upgrade to current software versions. These devices remain at their original firmware level and cannot receive subsequent software updates while deployed in the field.
The affected units are distributed nationwide across multiple U.S. states and Australia. The recall impacts 130 transmitters with specific serial numbers documented in FDA records.
Patients should contact their healthcare provider about their device status. Physicians are advised to contact Abbott Medical for guidance on device remediation or replacement. No adverse health events have been reported in association with this issue.
The recalled product
- Product
- Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (E
- Manufacturer
- Abbott Medical
- Affected units
- 130
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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