Company: Abbott Medical
Date of Enforcement Report: 11/26/2024
Class: III
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 (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server.
Recall Number:
Z-0551-2025
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Abbott Medical
VOLUME OF PRODUCT IN COMMERCE:
130 transmitters
DISTRIBUTION:
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.
