# FDA recall Z-0551-2025

> **Abbott Medical** · Class III · device recall initiated 2024-10-01.

## 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.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0551-2025
- **Recalling firm:** Abbott Medical
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-01
- **Report date:** 2024-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sylmar, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0551-2025

## Citation

> AI Analytics. FDA recall Z-0551-2025. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0551-2025. Source: US FDA. Licensed CC0.

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