Assert-IQ™ DM5000Recalls & reported problems
St. Jude Medical, Inc. · 3 Insertable Cardiac Monitor · Class 2 · Implant
Quick summary
This St. Jude Medical Assert-IQ is an implanted heart monitor that records heart rhythm. Its 217 reports mostly describe the monitor not transmitting or being read out, and losing its Bluetooth connection, with some describing battery and sensing problems. The reports include 31 injuries and no deaths. Reports rose from 65 in the prior 12 months to 126 in the latest 12 months. 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
- 226
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 226 adverse event reports that list this exact device (DI 05415067047793), received between Nov 7, 2023 and Sep 29, 2026 — classified as 32 injuries, 194 malfunctions.
The most frequently reported specific device problem is “Failure to Interrogate” (98 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 Interrogate98
- Under-Sensing29
- Premature Discharge of Battery26
- Interrogation Problem21
- Over-Sensing17
- Incorrect Measurement12
- Adverse Event Without Identified Device or Use Problem10
- Inappropriate or Unexpected Reset8
Patient problems
- No Clinical Signs, Symptoms or Conditions206
- Insufficient Information9
- Discomfort5
- Pocket Erosion5
- Unspecified Infection5
- Wound Dehiscence2
- Fatigue1
Recent adverse event reports
The 25 most recent of 226 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Inappropriate or Unexpected Reset; Interrogation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941063 ↗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, 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 ↗MalfunctionSep 28, 2026Failure to Interrogate
It was reported that the patient presented for a follow-up in clinic. It was noted the implantable cardiac monitor (ICM) could not be interrogated via Bluetooth telemetry and it had no magnet response. There were no reported consequences to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916347 ↗MalfunctionSep 23, 2026Data Problem
It was reported that the patient presented for a clinical follow-up. During the follow-up, an error message was encountered when attempting to print a loop session from the programmer. The issue occurred with loop recorder files and persisted when different printers were used. No intervention was performed, and there were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863336 ↗MalfunctionSep 18, 2026Inappropriate or Unexpected Reset
It was reported that the patient's implantable cardiac monitor (ICM) went into Backup mode. no further information was reported. Patient condition is unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819269 ↗MalfunctionSep 16, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794483 ↗InjurySep 16, 2026Failure to Interrogate
It was reported that the device was unable to be interrogated via Bluetooth (BLE) telemetry and had no magnet response. The device was explanted and replaced to resolve event. The patient was stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794051 ↗MalfunctionSep 14, 2026Under-Sensing
It was reported that the patient's insertable cardiac monitor (ICM) exhibited undersensing, potentially due to a loss of contact. No intervention was reported. The patient experienced no adverse consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749611 ↗MalfunctionSep 10, 2026Premature Discharge of Battery
It was reported that the patient's Insertable Cardiac Monitor (ICM) exhibited premature battery depletion. No intervention was performed. The patient had no adverse consequences due to the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717925 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient was reported that the patient presented to the clinic with mild protrusion of the Insertable Cardiac Monitor (ICM). The ICM was repositioned on (b)(6) 2026. Following the reposition procedure, the patient reported a sensation that the device was protruding from the implant site and applied a bandage over the area. The patient later reported that the device was no longer noticeable by the following morning. The patient remained in stable condition.
Patient problems: Discomfort; Pocket Erosion
MAUDE report 50693075 ↗MalfunctionSep 4, 2026Failure to Interrogate
It was reported that a patient's insertable cardiac monitor (ICM) was unable to be interrogated. No changes or interventions were reported. The patient condition was not reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50612614 ↗MalfunctionSep 2, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50576208 ↗MalfunctionSep 2, 2026Over-Sensing
Additional information received indicated the oversensing episodes were due to post-sensed T-wave oversensing and far P-wave oversensing. The device was reprogrammed to resolve the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50570691 ↗MalfunctionSep 2, 2026Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568929 ↗MalfunctionAug 29, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50510113 ↗MalfunctionAug 22, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50384324 ↗MalfunctionAug 19, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333278 ↗InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient's implantable cardiac monitor (ICM) had eroded through the incision site. No infection was noted and the wound healed. The ICM was explanted and a new ICM was implanted. The patient was stable throughout.
Patient problems: Pocket Erosion; Wound Dehiscence
MAUDE report 50245700 ↗MalfunctionAug 11, 2026Failure to Interrogate
It was reported that the patient's Insertable Cardiac Monitor (ICM) exhibited loss of Bluetooth telemetry. No intervention was performed. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50211412 ↗MalfunctionAug 11, 2026Failure to Interrogate
It was reported that the Insertable Cardiac Monitor exhibited Bluetooth telemetry loss. The patient was seen in clinic for device interrogation, but it was unclear whether the issue was resolved. There was no patient consequences reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50204294 ↗MalfunctionAug 10, 2026Under-Sensing
It was reported that a patient presented remotely via Merlin. Net, the implantable cardiac monitor (ICM) exhibited under sensing. No intervention or procedure was reported. The patient had no consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50189951 ↗MalfunctionAug 8, 2026Failure to Interrogate
It was reported that the Insertable Cardiac Monitor (ICM) was unable to be interrogated while still in packaging. The ICM was not used. The patient condition was not known.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50184629 ↗MalfunctionAug 4, 2026Failure to Interrogate
New information received notes that the patient presented in clinic and the issue was resolved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50131679 ↗
Other Recorder, event, implantable cardiac, (without arrhythmia detection) devices
- Assert-IQ™ DM5500St. Jude Medical, Inc. · Recorder, event, implantable cardiac, (without arrhythmia detection)951 reports
- 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
- 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.