Assert-IQ™ DM5300Recalls & reported problems
St. Jude Medical, Inc. · 3+ Insertable Cardiac Monitor · Class 2 · Implant
Quick summary
This St. Jude Medical Assert-IQ 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 its battery running down early, and most reports list no clinical signs for the patient. There are 919 reports, no deaths and 77 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
- 949
- Deaths reported
- 0
- Injuries reported
- 81
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 949 adverse event reports that list this exact device (DI 05415067047816), received between May 31, 2023 and Sep 30, 2026 — classified as 81 injuries, 868 malfunctions.
The most frequently reported specific device problem is “Under-Sensing” (310 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
- Under-Sensing310
- Failure to Interrogate223
- Premature Discharge of Battery127
- Over-Sensing95
- Incorrect Measurement85
- Interrogation Problem45
- Adverse Event Without Identified Device or Use Problem25
- Signal Artifact/Noise23
Patient problems
- No Clinical Signs, Symptoms or Conditions895
- Insufficient Information35
- Pocket Erosion16
- Unspecified Infection9
- Discomfort6
- Wound Dehiscence6
- Arrhythmia1
- Dizziness1
Recent adverse event reports
The 25 most recent of 949 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949935 ↗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, 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 28, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926513 ↗MalfunctionSep 28, 2026Premature Discharge of Battery
It was reported that the Insertable Cardiac Monitor (ICM) exhibited premature battery depletion. No intervention was reported. The patient condition was unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924023 ↗MalfunctionSep 28, 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 50915788 ↗MalfunctionSep 24, 2026Under-Sensing
It was reported that the patient presented to hospital for an implant procedure. During the procedure, it was noted that the implantable cardiac monitor (ICM) exhibited poor R-wave measurement resulting in undersensing. The ICM was not used. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876883 ↗InjurySep 23, 2026Migration or Expulsion of Device
It was reported that a patient's insertable cardiac monitor (ICM) was unable to be interrogated. A chest X-ray was performed and revealed that the ICM was no longer inside the patient's body. It is not known whether the patient removed the ICM or the ICM expulsed on its own.
Patient problems: Pocket Erosion
MAUDE report 50870235 ↗MalfunctionSep 23, 2026Under-Sensing
It was reported that the patient presented remotely via Merlin.net. Upon review, the implantable cardiac monitor exhibited undersensing episodes. Programming changes were made. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863232 ↗InjurySep 21, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848990 ↗InjurySep 21, 2026Premature Discharge of Battery
During an in-clinic follow-up, the device was found to be at elective replacement indicator (ERI) sooner than expected from the estimated longevity. Premature battery depletion was suspected. The device was explanted and replaced to resolve the event. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839165 ↗MalfunctionSep 18, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831615 ↗MalfunctionSep 18, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829724 ↗MalfunctionSep 18, 2026Under-Sensing
During a remote follow-up, undersensing episodes were observed on the device. Technical services was contacted and provided reprogramming recommendations. No intervention has been completed. The patient is stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820302 ↗MalfunctionSep 17, 2026Under-Sensing
During a remote follow up, under-sensing was noted on the device. Technical support was contacted and recommended reprogramming. The device was reprogrammed to resolve this event. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803551 ↗MalfunctionSep 16, 2026Under-Sensing
During a remote follow up, under-sensing was noted on the device. Technical support was contacted and recommended reprogramming. The device was reprogrammed to resolve this event. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788450 ↗InjurySep 15, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781312 ↗MalfunctionSep 15, 2026Premature Discharge of Battery
Patient problems: Insufficient Information
MAUDE report 50773956 ↗MalfunctionSep 15, 2026Premature Discharge of Battery
It was reported that the patient presented remotely via merlin.net. Review of transmission revealed that the Insertable Cardiac Monitor (ICM) exhibited premature battery depletion. No intervention was performed. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773492 ↗MalfunctionSep 15, 2026Premature Discharge of Battery
It was reported that the Insertable Cardiac Monitor (ICM) exhibited premature battery depletion. No intervention was reported. The patient condition was unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766526 ↗MalfunctionSep 14, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763689 ↗MalfunctionSep 14, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763492 ↗MalfunctionSep 14, 2026Premature Discharge of Battery
It was reported via a review of remote transmission that the Insertable Cardiac Monitor (ICM) is showing premature battery depletion. The patient is asymptomatic. No intervention was performed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753599 ↗MalfunctionSep 11, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743038 ↗
Other Recorder, event, implantable cardiac, (without arrhythmia detection) devices
- Assert-IQ™ DM5500St. Jude Medical, Inc. · Recorder, event, implantable cardiac, (without arrhythmia detection)951 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.