# FDA recall Z-0552-2025

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

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

## 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-0552-2025
- **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-0552-2025

## Citation

> AI Analytics. FDA recall Z-0552-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0552-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*