Merlin@home™ EX1150WRecalls & 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
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067034809), received between Nov 13, 2025 and Apr 17, 2026 — 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
Most reported problems
Device problems
- Break1
- Failure to Power Up1
- 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.
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 ↗MalfunctionNov 13, 2025Failure to Power Up; Failure to Power Up
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23547829 ↗
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- Medtronic CareLink® Programmer 2090AA4Medtronic, Inc. · Pacemaker/icd/crt non-implanted components3 recalls82 reports
- Entrant™ CDDRA300QSt. Jude Medical, Inc. · Pacemaker/icd/crt non-implanted components1 recall2 deaths158 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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