Merlin@homeRecalls & reported problems across all models
St. Jude Medical, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 367
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 1
We found 5 models of Merlin@home by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 367 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2018 and Sep 15, 2026 — classified as 8 injuries, 359 malfunctions.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (218 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Merlin@home recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 28, 2017Terminated
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
Z-0033-2018 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Most reported Merlin@home problems
Device problems
- Thermal Decomposition of Device218
- Failure to Power Up108
- Melted26
- Smoking26
- Break25
- Adverse Event Without Identified Device or Use Problem22
- Sparking22
- Defective Device8
Patient problems
- No Clinical Signs, Symptoms or Conditions193
- No Known Impact Or Consequence To Patient121
- No Information27
- Insufficient Information12
- No Patient Involvement7
- No Consequences Or Impact To Patient6
- Complaint, Ill-Defined1
- Discomfort1
Merlin@home models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Merlin@home™ EX1150Pulse generator, permanent, implantable353 reports
- Merlin@home™ EX1100Pulse generator, permanent, implantable1 recall2 reports
- Merlin@home™ EX1151Pulse generator, permanent, implantable8 reports
- Merlin@home™ EX1170TOOLS, PACEMAKER SERVICE2 reports
- Merlin@home™ EX1150WPacemaker/icd/crt non-implanted components2 reports
Recent Merlin@home adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionApr 17, 2026Break; Thermal Decomposition of Device
IT WAS REPORTED THAT THE PATIENT¿S HOME MONITORING TRANSMITTER WAS DAMAGED, WITH VISIBLE BURN DAMAGE OBSERVED. THE TRANSMITTER WAS EXCHANGED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24908354 ↗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 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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