Merlin@home™ EX1151Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734507011), received between Dec 27, 2019 and Nov 27, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (3 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT BURN MARKS WERE OBSERVED ON THE TRANSMITTER'S USB CELLULAR ADAPTER. THE TRANSMITTER WITH ADAPTER WAS EXCHANGED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20802693 ↗
• InjuryOct 31, 2023Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE DEVICE INAPPROPRIATELY DELIVERED ANTITACHYCARDIA PACING FOR SUPRAVENTRICULAR TACHYCARDIA. ABBOTT TECHNICAL SUPPORT RECOMMENDED REPROGRAMMING TO RESOLVE THE EVENT, HOWEVER, NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18043183 ↗
• MalfunctionAug 17, 2022Over-Sensing; Device Sensing Problem; Over-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. UPON REVIEW OF TRANSMISSION, IT WAS FOUND THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED R-WAVE AMPLITUDE VARIATION AND MYOPOTENTIAL OVER-SENSING. PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245521 ↗
• MalfunctionApr 1, 2022Thermal Decomposition of Device; Smoking; Thermal Decomposition of Device; Smoking

  IT WAS REPORTED THAT THE GREEN STRIPES ON THE TRANSMITTER'S ALTERNATING CURRENT (AC) POWER ADAPTER LOOKED BURNT AND VISIBLE SMOKE WAS OBSERVED. THE AC POWER ADAPTER WAS REPLACED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13981339 ↗
• MalfunctionOct 5, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  PRIOR TO AN DEVICE REPLACEMENT DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI), THE DEVICE WAS INTERROGATED AND WAS OBSERVED TO BE IN BACKUP MODE. THE EVENT WAS RESOLVED BY EXPLANTING AND REPLACING THE DEVICE DUE TO NORMAL ERI. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577571 ↗
• MalfunctionSep 9, 2021Pacing Problem; Pacing Problem

  DURING A CLINIC FOLLOW-UP, THE LOW VOLTAGE OUTPUT PACING ON THE DEVICE WAS LOWER THAN THE PROGRAMMING MINIMUM VOLTAGE. THE DEVICE WAS REPROGRAMMING AS AN INTERIM RESOLUTION AS THE DEVICE IS ANTICIPATED TO BE EXPLANTED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447194 ↗
• MalfunctionMar 2, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT A BURN MARK WAS OBSERVED AROUND THE USB CORD OF CELL ADAPTER. THE DEVICE WOULD BE REPLACED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11400404 ↗
• MalfunctionDec 27, 2019Melted; Melted

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-18569. IT WAS REPORTED THAT DURING A SCHEDULED DATA TRANSMISSION, THE MERLIN TRANSMITTER USB PORT AND USB CELLULAR ADAPTER WERE SUSPECTED TO HAVE BEEN MELTED DUE TO HEAD CAUSED BY LONGTIME USE. THE DEVICES WERE REPLACED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9527813 ↗