Merlin@home™ EX1170Recalls & reported problems

St. Jude Medical, Inc. · Wireless Broadband Kit · Class 1

All models of Merlin@home (5)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734504706), received between Oct 8, 2024 and May 27, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break1
Melted1
Thermal Decomposition of Device1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 27, 2025Break; Melted; Break; Melted
IT WAS REPORTED THAT THE ANTENNAS OF A WIRELESS BROADBAND INTERNET KIT HAVE MELTED AND BROKEN OFF. NO ADVERSE EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22089506 ↗
MalfunctionOct 8, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT THE PATIENT'S WI-FI KIT FOR THEIR MERLIN TRANSMITTER WAS BURNT. THE PRODUCT WAS REPLACED TO RESOLVE THE EVENT AND THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20402572 ↗

Device details

UDI-DI	`05414734504706`
Brand	Merlin@home™
Model	EX1170
Company	St. Jude Medical, Inc.
Product code	DTF · TOOLS, PACEMAKER SERVICE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 12, 2024

Device type (GMDN): Transtelephonic implantable pacemaker analysis system

An assembly of devices designed to analyse the performance of an implanted pacemaker based on electrocardiographic measurements that can be monitored transtelephonically. It typically includes a computer-based pacemaker analyser, a 12-lead electrocardiograph (ECG), and a transtelephonic receiver and/or transmitter. It provides data taken directly from the patient (e.g., ECG electrodes are applied to the patient and a test magnet is placed over the pacemaker to activate it) or a pacemaker programmer. Signals are sent to the receiver where pacemaker function information is displayed. This system may also include a database that collects and stores patient data.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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