Merlin@home™ EX1100Recalls & 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
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734504782), received between Jan 17, 2024 and Aug 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
1 FDA recall record name this device's 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, 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
Recalls naming this device
- Aug 28, 2017Class IITerminated
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 problems
Device problems
- Break2
- 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.
MalfunctionAug 18, 2025Break; Break
IT WAS REPORTED THAT THE MERLIN TRANSMITTER HAD A BROKEN PRONGS. THE PRONGS WERE REMOVED AND BURN DAMAGE WAS NOTED. TRANSMITTER WAS NOT USED AND REPLACED. NO PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22835918 ↗MalfunctionJan 17, 2024Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device
IT WAS REPORTED A PATIENT'S TRANSMITTER PRESENTED WITH DAMAGED AND BURNT CONTACTS. NO CHANGES WERE REPORTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531249 ↗
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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 · each recall links to the FDA recall notice
- 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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