INGENIO™ K174Recalls & reported problems

Summary

The FDA's MAUDE database contains 678 adverse event reports that list this exact device (DI 00802526536786), received between Apr 22, 2016 and Sep 29, 2026 — classified as 2 deaths, 558 injuries, 118 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (355 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 678 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Signal Artifact/Noise

  It was reported that this pacemaker was explanted due to a product performance issue. This pacemaker was successfully explanted and replaced with another device. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned for analysis.Additional information was received that the RV lead exhibited a fracture that caused noisy signals. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936778 ↗
• InjurySep 25, 2026Extracardiac stimulation; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50904156 ↗
• InjurySep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information

  It was reported that this device was explanted due to an unknown product anomaly. A new device was successfully implanted. No additional adverse patient effects were reported. This device is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872607 ↗
• MalfunctionSep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831101 ↗
• InjurySep 16, 2026Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information

  It was reported that this pacemaker was explanted due to an unknown product performance issue. This pacemaker was successfully replaced. No additional adverse patient effects were reported.Additional information was received. This pacemaker was explanted due to reverting to safety mode.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793071 ↗
• MalfunctionSep 14, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757277 ↗
• InjurySep 14, 2026Over-Sensing; Failure to Read Input Signal

  It was reported that this pacemaker exhibited low amplitudes and oversensing. Subsequently, this pacemaker was explanted due to unknown reasons. Additional information was requested but unable to be obtained at this time. This pacemaker was successfully replaced and no additional adverse patient effects were reported. This pacemaker was returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50748222 ↗
• InjurySep 9, 2026Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker switched into Safety Mode for patient protection, as a code 1003 was noted prior. Technical Services (TS) discussed the immediate replacement of the device. Subsequently, this pacemaker was successfully replaced. No additional adverse patient effects were reported outside the revision procedure. At this time, this pacemaker has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695464 ↗
• InjurySep 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50658541 ↗
• InjurySep 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50650906 ↗
• InjurySep 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker reverted to Safety Mode. However, this device recovered and exited Safety Mode. Technical Services (TS) advised this behavior can occur occasionally and suggested the device should be replaced. Subsequently, this device was explanted as TS suggested. Another device was implanted to complete this procedure. This device is expected to be returned but has not yet been received. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602344 ↗
• InjurySep 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that during a clinic visit, this pacemaker was found to be operating in safety mode. Later on, a replacement procedure was performed. This pacemaker was explanted and replaced with a new device successfully. No additional adverse effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601330 ↗
• InjuryAug 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50509689 ↗
• InjuryAug 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that during a clinic visit, this pacemaker was found to be operating in safety mode. Subsequently, a replacement procedure was performed. This pacemaker was explanted and replaced with a new device successfully. No additional adverse effects were reported. This pacemaker was returned to facility awaiting analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383824 ↗
• InjuryAug 16, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker reverted to Safety Mode. This pacemaker was explanted and another pacemaker was implanted to complete this procedure. This device was returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50267135 ↗
• InjuryAug 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker was found to be in safety mode. Subsequently, a replacement procedure was performed. This pacemaker was explanted and replaced with a new device successfully. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225877 ↗
• InjuryAug 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker was found to be in Safety Mode. Technical Services (TS) discussed Safety Mode and recommended device replacement. Subsequently, this device was explanted and replaced with a new device. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223125 ↗
• InjuryAug 11, 2026Interrogation Problem

  It was reported that this pacemaker was unable to be interrogated during a routine visit. Additionally, the patient felt unwell and experienced a seizure during this visit. Technical Services (TS) was consulted and determined that Elective Replacement Indicator had triggered months prior and that the device was likely at End of Life status. TS noted no device interrogation was completed as the local field representative aided staff in helping the patient to the ambulance. The local field representative confirmed that the patient was hospitalized. No additional adverse patient effects were reported. This pacemaker remains in service.

  Patient problems: Discomfort; Loss of consciousness

  MAUDE report 50208528 ↗
• InjuryAug 10, 2026Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  It was reported that this pacemaker reverted to Safety Mode. The physician confirmed there was no programming response. Technical Services (TS) recommended device replacement. This pacemaker was explanted, replaced, and returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50197018 ↗
• MalfunctionAug 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker reverted to Safety Mode. Technical Services (TS) was contacted and recommended device replacement. The patient was stated to have a sinus rhythm of 37 beats per minute (BPM). This pacemaker remains in service. No adverse patient effects were reported.

  Patient problems: Bradycardia

  MAUDE report 50197002 ↗
• MalfunctionAug 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker triggered a safety mode and reached Elective Replacement Indicator. It was recommended to explant the pacemaker but remains in service at this time. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50189692 ↗
• MalfunctionAug 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168795 ↗
• MalfunctionAug 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50166731 ↗
• MalfunctionAug 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50149928 ↗
• InjuryJul 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that during a clinic visit, this pacemaker was found to be in safety mode. Subsequently, a replacement procedure was performed. This pacemaker was explanted and replaced with new device successfully. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060094 ↗