INGENIORecalls & reported problems across all models

We found 3 models of INGENIO by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,606 adverse event reports in the FDA's MAUDE database, received between Jan 8, 2015 and Sep 29, 2026 — classified as 8 deaths, 1,111 injuries, 487 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (372 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 INGENIO problems

INGENIO models

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

• INGENIO™ K173

  Implantable pulse generator, pacemaker (non-CRT)
  6 deaths874 reports
• INGENIO™ K174

  Implantable pulse generator, pacemaker (non-CRT)
  2 deaths678 reports
• INGENIO™ K172

  Implantable pulse generator, pacemaker (non-CRT)
  54 reports

Recent INGENIO adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602087 ↗
• 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 ↗

Other Boston Scientific Corporation products

• INGEVITY MRI7 models · 16,601 reports
• INGEVITY+3 models · 16,054 reports
• EMBLEM S-ICD4 models · 13,295 reports · 1 recall
• WATCHMAN25 models · 8,024 reports · 6 recalls
• AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
• ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
• RELIANCE 4-FRONT11 models · 5,739 reports
• FINELINE II EZ Sterox6 models · 5,633 reports