Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capabil

FDA device recall Z-0552-2025 · posted 2024-11-26 · Open, Classified

Recall details

Recalling firm

Abbott Medical

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.

Action taken

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

Status

Open, Classified

Product code

NVZ

Quantity affected

Pending

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, M

Date initiated

2024-10-01

Date posted

2024-11-26

Location

Sylmar, CA