Merlin@home™ EX1150Recalls & reported problems
St. Jude Medical, Inc. · Transmitter · Class 3
All models of Merlin@home (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Merlin@home transmitter sends data from a patient's implanted heart device. Of its 354 reports, 347 describe malfunctions and 7 describe injuries, with no deaths. Most describe the transmitter overheating, burning, sparking or failing to power on, and most reports record no patient effects. No recalls name this device, and reports fell to 30 in the last 12 months from 58 before that.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 353
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 353 adverse event reports that list this exact device (DI 05414734504799), received between Jun 22, 2018 and Sep 15, 2026 — classified as 7 injuries, 346 malfunctions.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (212 reports).
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
Most reported problems
Device problems
- Thermal Decomposition of Device212
- Failure to Power Up107
- Smoking25
- Melted24
- Adverse Event Without Identified Device or Use Problem22
- Sparking22
- Break21
- Defective Device8
Patient problems
- No Clinical Signs, Symptoms or Conditions180
- No Known Impact Or Consequence To Patient120
- No Information27
- Insufficient Information12
- No Patient Involvement7
- No Consequences Or Impact To Patient6
- Complaint, Ill-Defined1
- Discomfort1
Recent adverse event reports
The 25 most recent of 353 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Thermal Decomposition of Device
It was reported that smoke was observed emanating from the patient's transmitter. The transmitter was not used and exchanged with a new transmitter. No patient consequences were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766043 ↗MalfunctionAug 28, 2026Failure to Power Up; Sparking
It was reported that the Merlin Home Transmitter exhibited sparking and subsequently failed to power on during a transmission attempt. The transmitter was not used. No additional adverse patient effects were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50492238 ↗MalfunctionAug 20, 2026Break
The external device was returned. During device analysis charring was observed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50347321 ↗MalfunctionJun 23, 2026Smoking
IT WAS REPORTED THAT THE TRANSMITTER CAUGHT FIRE DURING TRANSMISSION. THE TRANSMITTED WAS NOT USED. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS AND REMAINED IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25589747 ↗MalfunctionMay 27, 2026Break; Thermal Decomposition of Device
IT WAS REPORTED THAT THE TRANSMITTER'S POWER CORD WAS BROKEN. THE CABLE WAS BURNED, WITH INTERNAL WIRES VISIBLE AND APPEARING SPLICED. THE TRANSMITTER WAS REPLACED, AND NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25311382 ↗MalfunctionMay 13, 2026Thermal Decomposition of Device; Wireless Communication Problem
IT WAS REPORTED THAT THE MERLIN TRANSMITTER DISPLAYED A READ ERROR. UPON VISUAL INSPECTION, THE SILVER STRIPS WITHIN THE POWER PLUG APPEARED BURNED. AS A RESULT, THE TRANSMITTER WAS NOT USED AND WAS REPLACED. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157458 ↗MalfunctionMay 8, 2026Thermal Decomposition of Device
IT WAS REPORTED THAT THE POWER CORD OF THE TRANSMITTER WAS MELTED. THE TRANSMITTER WAS SUBSEQUENTLY REPLACED. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25120574 ↗MalfunctionMay 3, 2026Thermal Decomposition of Device; Failure to Power Up
IT WAS REPORTED THAT THE TRANSMITTER FAILED TO POWER UP DUE TO THE RIGHT METAL PRONG BEING BURNT. THE TRANSMITTER WAS SUBSEQUENTLY REPLACED. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25064355 ↗MalfunctionApr 29, 2026Thermal Decomposition of Device
IT WAS REPORTED THAT THE TRANSMITTER WOULD NOT POWER ON DUE TO A BURNT POWER ADAPTER. THE TRANSMITTER WAS NOT USED AND REPLACED. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25024952 ↗MalfunctionMar 25, 2026Display or Visual Feedback Problem; Melted; No Tactile Prompts/Feedback
IT WAS REPORTED THAT THE MERLIN HOME TRANSMITTER EXHIBITED UNUSUAL LIGHTS, AN UNRESPONSIVE START BUTTON AND A MELTED PLUG. THE TRANSMITTER WAS NOT USED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24684554 ↗MalfunctionMar 16, 2026Break; Thermal Decomposition of Device
IT WAS REPORTED THAT THE PATIENT'S TRANSMITTER POWER CORD WAS BROKEN AND THAT THE CABLES EXTENDING FROM THE POWER CORD APPEARED BURNED. THERE WERE NO PATIENT CONSEQUENCES. THE TRANSMITTER WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24602692 ↗MalfunctionFeb 13, 2026Break; Thermal Decomposition of Device
IT WAS REPORTED THAT THE POWER CORD OF A PATIENT¿S TRANSMITTER WAS PHYSICALLY DAMAGED AND WAS FRIED. THERE WERE NO CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24338400 ↗MalfunctionJan 22, 2026Failure to Power Up; No Apparent Adverse Event
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24156678 ↗MalfunctionJan 22, 2026Break
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24155130 ↗MalfunctionJan 13, 2026Thermal Decomposition of Device; Melted
IT WAS REPORTED THAT THE TRANSMITTER POWER CORD MELTED BECAUSE THE TRANSMITTER CONNECTED TO AN EXTENSION CORD CAUGHT FIRE. THE TRANSMITTER WAS REMOVED AND REPLACED. THERE WERE NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064147 ↗MalfunctionJan 13, 2026No Apparent Adverse Event
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 24059272 ↗MalfunctionJan 5, 2026No Apparent Adverse Event
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 23968572 ↗MalfunctionDec 17, 2025Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device
NEW INFORMATION RECEIVED NOTES THAT THE PATIENT DID NOT REPORT ANY ALLEGATION REGARDING THE TRANSMITTER POWER CORD BEING BURNT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835407 ↗MalfunctionDec 8, 2025Failure to Power Up; Failure to Power Up
THIS REPORT IS TO ADVISE OF AN EVENT THAT WAS OBSERVED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744021 ↗MalfunctionDec 5, 2025Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up
IT WAS REPORTED THAT THE PATIENT'S TRANSMITTER DID NOT LIGHT UP AND THERE WAS EVIDENCE OF A BURN ON THE POWER CORD. THE TRANSMITTER WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23733163 ↗MalfunctionDec 1, 2025Thermal Decomposition of Device; Display or Visual Feedback Problem; Thermal Decomposition of Device; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE TRANSMITTER COULD NOT BE USED, AND THE LIGHT ON THE PATIENT'S TRANSMITTER WAS DIM. THE ISSUE WAS TRACED TO A BURNT POWER ADAPTER. THE TRANSMITTER WAS REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23677487 ↗MalfunctionNov 25, 2025Failure to Power Up; Failure to Power Up
THE EXTERNAL DEVICE WAS RETURNED. DURING DEVICE ANALYSIS BURNT COMPONENTS WERE OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23650855 ↗MalfunctionNov 21, 2025Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up
IT WAS REPORTED THAT THE PATIENT'S TRANSMITTER FAILED TO TURN ON AND HAD BURNT PRONGS. THE TRANSMITTER WAS NO LONGER USED. THE PATIENT HAD NO CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23619007 ↗MalfunctionNov 20, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE NO LONGER POWERED UP. THERE WERE NO CONSEQUENCES TO THE PATIENT. THE TRANSMITTER WAS RETURNED AND DURING ANALYSIS, BURNT COMPONENTS WERE OBSERVED ON THE CIRCUIT BOARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605070 ↗MalfunctionNov 19, 2025Failure to Power Up; Failure to Power Up
THE EXTERNAL DEVICE WAS RETURNED. DURING DEVICE ANALYSIS BURNT COMPONENTS WERE OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23596134 ↗
Other Pulse generator, permanent, implantable devices
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- Edora 8 DR-T 407145BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable10 deaths982 reports
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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