Merlin™ 2Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05415067031174), received between Jul 13, 2022 and Jun 25, 2026 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Thermal Decomposition of Device; Failure to Power Up; No Apparent Adverse Event; Unexpected Shutdown

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627173 ↗
• MalfunctionJun 23, 2026Communication or Transmission Problem; No Tactile Prompts/Feedback

  DURING AN IN-CLINIC FOLLOW-UP, THE PROGRAMMER'S TOUCH SCREEN WAS RESPONSIVE BUT NOT FUNCTIONING CORRECTLY AND THE PROGRAMMER WASN'T PROGRAMMING THE DEVICE AS DESIRED. THE PROGRAMMER SWITCHED TO NO PACING MODE (ODO MODE) UNPROMPTED. THE PATIENT IS PACEMAKER DEPENDENT, HOWEVER NO ADVERSE EVENT OCCURRED. A DIFFERENT PROGRAMMER WAS USED TO PROGRAM BACK TO DESIRED SETTINGS. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25598577 ↗
• MalfunctionJan 7, 2026Data Problem; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 23987137 ↗
• MalfunctionDec 18, 2025Sparking; Data Problem; Sparking; Data Problem

  IT WAS NOTED THAT A SPARK AND ERROR MESSAGE WERE OBSERVED UPON SWITCHING THE MERLIN PROGRAMMER. THE MERLIN PROGRAMMER WAS NOT USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835971 ↗
• InjuryApr 18, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  DURING A THRESHOLD TEST, THE PROGRAMMER FROZE AND CAUSED A LOSS OF PACING AND ASYSTOLE IN A PACEMAKER DEPENDENT PATIENT. THE PROGRAMMER WAS REPLACED AFTER THE EVENT, BUT NO FURTHER INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 21868337 ↗
• InjuryMar 14, 2025Program or Algorithm Execution Failure; Program or Algorithm Execution Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-17541. IT WAS REPORTED THAT DURING AN IN-CLINIC FOLLOW-UP, WHILE PERFORMING REGULAR THRESHOLD TESTING, THE PROGRAMMER EXHIBITED A THRESHOLD TESTING DECREMENT ISSUE AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOSS OF CAPTURE, WHICH RESULTED IN PATIENT EXPERIENCING AN ARRHYTHMIA. IT WAS NOTED THAT AFTER THE TESTING WAS COMPLETED AND THE ICD WAS RETURNED TO PROGRAMMED SETTINGS, THE PATIENT EXPERIENCED DIZZINESS. NO INTERVENTION WAS PERFORMED. PATIENT CONDITION WAS UNKNOWN.

  Patient problems: Arrhythmia; Dizziness

  MAUDE report 21612847 ↗
• MalfunctionApr 16, 2024Thermal Decomposition of Device; Unexpected Shutdown; Thermal Decomposition of Device; Unexpected Shutdown

  DURING THE LEAD PARAMETER CHECKUP PROCEDURE, THE PROGRAMMER WAS SHUTDOWN UNEXPECTEDLY AND THE PROGRAMMER FUSE WAS BURNT. THE PROGRAMMER WAS NOT USED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113783 ↗
• MalfunctionMar 22, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED AN INCORRECT LONGEVITY ESTIMATE BECAUSE OF A BATTERY LONGEVITY CALCULATION OVERESTIMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960208 ↗
• MalfunctionNov 7, 2023Program or Algorithm Execution Failure; Program or Algorithm Execution Failure

  DURING AN IN-CLINIC FOLLOW-UP, A NONINVASIVE PACING STUDY (NIPS) WAS PERFORMED. BURST PACING WAS INITIATED USING THE MERLIN PROGRAMMER, HOWEVER, UPON RELEASING THE BUTTON ON THE PROGRAMMER, THE BURST PACING DID NOT IMMEDIATELY TERMINATE. THE BURST PACING CONTINUED FOR ABOUT 4 ADDITIONAL SECONDS BEFORE EVENTUALLY CEASING. THE WERE NO ADVERSE CONSEQUENCES DUE TO THE PROLONGED PACING. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084931 ↗
• MalfunctionSep 7, 2023Program or Algorithm Execution Problem; Program or Algorithm Execution Problem

  DURING AN IN-CLINIC FOLLOW-UP, A THRESHOLD DECREMENT TEST WAS PERFORMED. ONCE THE DEVICE REACHED A LOSS OF CAPTURE, THE PHYSICIAN RELEASED THE TEST BUTTON ON THE MERLIN PROGRAMMER, HOWEVER, THE DECREMENT TEST DID NOT END AS EXPECTED. THE CAPTURE THRESHOLD CONTINUED TO DROP UNTIL THE TEST COMPLETED ON ITS OWN. THE PATIENT WAS NOT PACEMAKER DEPENDENT AND, THEREFORE, DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES DUE TO THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703671 ↗
• InjuryMay 16, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PROGRAMMER FROZE WHILE PERFORMING A LEFT VENTRICULAR CAPTURE THRESHOLD TEST. AS A RESULT, THE PATIENT EXPERIENCED ASYSTOLE. THE TEST COMPLETED AND PACING SUPPORT WAS REESTABLISHED AUTOMATICALLY. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 16942102 ↗
• MalfunctionMar 10, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  FOLLOWING THE INITIAL IMPLANT PROCEDURE WHEN RUNNING A MANUAL THRESHOLD TEST, THE PROGRAMMER FROZE WHILE PACING THE LEFT VENTRICLE AT 90 BPM. THE PACING DID NOT SELF TERMINATE AND THE PROGRAMMER WAS UNRESPONSIVE. THE PROGRAMMER WAS TURNED OFF IN ORDER TO RESTORE NORMAL PACING. AFTER THE PROGRAMMER WAS RESTARTED, ALL TESTS WERE COMPLETED NORMALLY. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16523959 ↗
• MalfunctionFeb 3, 2023Program or Algorithm Execution Failure; Program or Algorithm Execution Failure

  DURING A ROUTINE CLINIC FOLLOW-UP, WHEN TESTING THE CAPTURE THRESHOLD, A LOSS OF CAPTURE WAS NOTED. WHEN NOTED, AN ATTEMPT WAS UNSUCCESSFULLY MADE TO CANCEL THE CAPTURE TESTING. THE TEST SEEMED TO CONTINUE FOR A TOTAL OF 8 PACES AND THEN THE EVENT WAS RESOLVED. THE PATIENT WAS STABLE AND NO FURTHER INTERVENTION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16297081 ↗
• MalfunctionSep 12, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED AN INCORRECT LONGEVITY ESTIMATE BECAUSE OF A BATTERY LONGEVITY CALCULATION OVERESTIMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403215 ↗
• InjurySep 7, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED AN INCORRECT LONGEVITY ESTIMATE BECAUSE OF A BATTERY LONGEVITY CALCULATION OVERESTIMATION. THE PATIENT¿S PULSE GENERATOR WAS EXPLANTED PRIOR TO REACHING ITS ELECTIVE REPLACEMENT INDICATOR (ERI). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-22610.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374389 ↗
• MalfunctionAug 11, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED AN INCORRECT LONGEVITY ESTIMATE BECAUSE OF A BATTERY LONGEVITY CALCULATION OVERESTIMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209802 ↗
• MalfunctionAug 9, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED AN INCORRECT LONGEVITY ESTIMATE BECAUSE OF A BATTERY LONGEVITY CALCULATION OVERESTIMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15192143 ↗
• MalfunctionJul 13, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED AN INCORRECT LONGEVITY ESTIMATE BECAUSE OF A BATTERY LONGEVITY CALCULATION OVERESTIMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008298 ↗