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Open, Classified

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 emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN

FDA Recall Z-0552-2025 · Posted 2024-11-26

Recalling FirmAbbott Medical
Recall StatusOpen, Classified
Product CodeNVZ
Date Initiated2024-10-01
Product QuantityPending

Reason for Recall

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.

Firm Action

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

Root Cause

Software design

Distribution Pattern

Worldwide - U.S. Nationwide distribution in the states of 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. The country of Australia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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