Assert-IQRecalls & reported problems across all models

We found 4 models of Assert-IQ by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 2,128 adverse event reports in the FDA's MAUDE database, received between May 31, 2023 and Sep 30, 2026 — classified as 222 injuries, 1,905 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (604 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. 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

Most reported Assert-IQ problems

Assert-IQ models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Assert-IQ™ DM5500

  Recorder, event, implantable cardiac, (without arrhythmia detection)
  951 reports
• Assert-IQ™ DM5300

  Recorder, event, implantable cardiac, (without arrhythmia detection)
  949 reports
• Assert-IQ™ DM5000

  Recorder, event, implantable cardiac, (without arrhythmia detection)
  226 reports
• Assert-IQ™ DM5100

  Recorder, event, implantable cardiac, (with arrhythmia detection)
  2 reports

Recent Assert-IQ adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952136 ↗
• MalfunctionSep 30, 2026Premature Discharge of Battery

  It was reported that the patient's Insertable Cardiac Monitor (ICM) exhibited premature battery depletion. No intervention was performed and no patient consequences were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951320 ↗
• MalfunctionSep 30, 2026Premature Discharge of Battery

  It was reported that the patient presented in the clinic for follow up. Upon device interrogation, it was noted that the Implantable Cardiac Monitor (ICM) exhibited premature battery depletion. No intervention was performed. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951130 ↗
• MalfunctionSep 30, 2026Failure to Interrogate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949935 ↗
• InjurySep 30, 2026Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that the patient's Insertable Cardiac Monitor (ICM) was suspected to exhibit premature battery depletion due to an incorrect measurement of battery longevity that later returned to its appropriate value. Afterwards, it was noted that ICM exhibited premature Elective Replacement Indicator (ERI) and was confirmed to exhibit early battery depletion. The ICM was explanted and replaced. The patient had no consequences due to the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947602 ↗
• MalfunctionSep 30, 2026Under-Sensing

  It was reported through a remote transmission that the patient's implantable cardiac monitor (ICM) recorded false positive episodes due to under-sensing. Programming changes were made. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941946 ↗
• MalfunctionSep 29, 2026Inappropriate or Unexpected Reset

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941398 ↗
• MalfunctionSep 29, 2026Inappropriate or Unexpected Reset; Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941063 ↗
• OtherSep 29, 2026Failure to Interrogate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938031 ↗
• MalfunctionSep 29, 2026Failure to Interrogate

  It was reported that a patient's insertable cardiac monitor (ICM) was unable to be interrogated despite troubleshooting attempts. Extended magnet placement was performed, but the ICM was unable to interrogated. The patient condition was not reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936718 ↗
• MalfunctionSep 29, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Interpretation of Signal; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934102 ↗
• MalfunctionSep 29, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928378 ↗
• MalfunctionSep 29, 2026Over-Sensing

  It was reported that the patient¿s insertable cardiac monitor exhibited post sense T-wave oversensing. No intervention was performed. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927869 ↗
• MalfunctionSep 29, 2026Failure to Interrogate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926759 ↗
• MalfunctionSep 29, 2026Failure to Interrogate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926721 ↗

Other St. Jude Medical, Inc. products

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