Merlin@home Transmitter with MerlinOnDemand (Abbott) – Software Upgrade Failure (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in eme
Brand
Abbott Medical
Lot Codes / Batch Numbers
Model Number: EX1150 UDI-DI code: Pending Serial Numbers: Pending
Products Sold
Model Number: EX1150 UDI-DI code: Pending Serial Numbers: Pending
Abbott Medical is recalling Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOn due to Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
Recommended Action
Per FDA guidance
On 10/25/2024, the firm initiated notifying customers in person/verbally regarding a limited number of Merlin@home Transmitters with MerlinOnDemand Capability that are unable to upgrade to the latest version of software. This issue was caused by a power interruption during a past software updated attempt. Abbott will be retrieving and replacing the affected Transmitters. The replacement Transmitter will have the latest software update version 9.0rev1 For questions or further assistance, speak with or contact the Abbott representative that is on-site replacing the Transmitter, or contact the Public Contact at 408-845-3427
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026