Assert-IQ™ DM5500Recalls & reported problems
St. Jude Medical, Inc. · EL+ Insertable Cardiac Monitor · Class 2 · Implant
Quick summary
This St. Jude Medical Assert-IQ EL+ insertable cardiac monitor is a small device placed under the skin to record heart rhythm. Reports mostly describe the monitor missing heart signals, clinics being unable to read it, and batteries running down early. There are 913 reports, no deaths and 107 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 951
- Deaths reported
- 0
- Injuries reported
- 109
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 951 adverse event reports that list this exact device (DI 05415067047809), received between Jun 26, 2023 and Sep 30, 2026 — classified as 109 injuries, 841 malfunctions.
The most frequently reported specific device problem is “Failure to Interrogate” (265 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Interrogate265
- Under-Sensing265
- Over-Sensing135
- Premature Discharge of Battery102
- Incorrect Measurement73
- Inappropriate or Unexpected Reset72
- Adverse Event Without Identified Device or Use Problem33
- Data Problem27
Patient problems
- No Clinical Signs, Symptoms or Conditions867
- Insufficient Information65
- Discomfort19
- Pocket Erosion17
- Unspecified Infection10
- Wound Dehiscence6
- Hypersensitivity/Allergic reaction3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 951 reports, 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 ↗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 ↗OtherSep 29, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938031 ↗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 28, 2026Under-Sensing
It was reported that an alert occurred during a remote follow up. The alert was for repeat false positive pauses due to under sensing with a loop recorder. To address the issue, sensitivity was remotely programmed. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917353 ↗MalfunctionSep 28, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917178 ↗MalfunctionSep 28, 2026Premature Discharge of Battery
It was reported that during remote follow-up, the patient's Insertable Cardiac Monitor (ICM) exhibited premature battery depletion. No changes or interventions were reported. The patient condition was not known.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916214 ↗MalfunctionSep 24, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50891626 ↗MalfunctionSep 24, 2026Failure to Interrogate
It was reported that the Insertable Cardiac Monitor exhibited Bluetooth telemetry loss. No intervention was performed. The patient's status was unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888680 ↗MalfunctionSep 24, 2026Premature Discharge of Battery
It was reported during in clinic follow up that the Insertable Cardiac Monitor (ICM) exhibited premature battery depletion. The product will continue to be monitored. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883279 ↗MalfunctionSep 24, 2026Incorrect Measurement
It was reported that the patient was monitored remotely via Merlin.net. Review of the transmission showed that the Insertable Cardiac Monitor (ICM) exhibited false-positive bradycardia episodes on the Electrogram (EGM). Programming changes were made. The patient remained in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876698 ↗MalfunctionSep 24, 2026Under-Sensing
It was reported that the patient was monitored remotely via Merlin.net. Review of the transmissions showed that the Insertable Cardiac Monitor (ICM) exhibited a false-positive pause due to undersensing. Programming changes were made. The patient remained in stable condition and continued to be monitored.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876655 ↗MalfunctionSep 23, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873352 ↗InjurySep 23, 2026Premature Discharge of Battery
It was reported that the Insertable Cardiac Monitor (ICM) exhibited premature battery depletion. The physician explanted and replaced the ICM. The patient condition was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872792 ↗MalfunctionSep 23, 2026Under-Sensing
It was reported that the patient presented remotely via Merlin.net. Review of the transmission revealed that the implantable cardiac monitor (ICM) exhibited under-sensing of intrinsic activities, resulting in false bradycardia episodes. No intervention or changes were reported. No patient consequences were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869290 ↗MalfunctionSep 23, 2026Failure to Interrogate
It was reported that the implantable cardiac monitor (ICM) exhibited Bluetooth (BLE) telemetry loss. No intervention was performed. There were no patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867938 ↗MalfunctionSep 22, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862148 ↗MalfunctionSep 22, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860689 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced discomfort associated with the insertable cardiac monitor (ICM) when lying on his side. The ICM was subsequently explanted. No patient consequences were reported.
Patient problems: Discomfort
MAUDE report 50856470 ↗MalfunctionSep 22, 2026Failure to Interrogate
It was reported that the implantable cardiac monitor (ICM) exhibited Bluetooth (BLE) telemetry loss. No intervention was performed. There were no patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853607 ↗MalfunctionSep 22, 2026Under-Sensing
It was reported that the patient's insertable cardiac monitor (ICM) was implanted on (b)(6) 2026. A subsequent Merlin.net transmission revealed that the ICM exhibited undersensing, potentially due to a loss of contact. No intervention and adverse patient outcome was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50850451 ↗InjurySep 18, 2026Premature Discharge of Battery
It was reported that the patient presented for in clinic follow-up. Device interrogation revealed that the Insertable Cardiac Monitor (ICM) exhibited premature battery depletion. The physician explanted and replaced the ICM. The patient condition was unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827408 ↗
Other Recorder, event, implantable cardiac, (without arrhythmia detection) devices
- Assert-IQ™ DM5300St. Jude Medical, Inc. · Recorder, event, implantable cardiac, (without arrhythmia detection)949 reports
- SJM CONFIRM™ DM2102St. Jude Medical, Inc. · RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)251 reports
- Assert-IQ™ DM5000St. Jude Medical, Inc. · Recorder, event, implantable cardiac, (without arrhythmia detection)226 reports
- SJM CONFIRM™ DM2100St. Jude Medical, Inc. · RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)2 deaths53 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.