VITALIORecalls & reported problems across all models

We found 3 models of VITALIO by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 296 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2016 and Sep 29, 2026 — classified as 1 death, 245 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (137 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 VITALIO problems

VITALIO models

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

• VITALIO™ K274

  Implantable pulse generator, pacemaker (non-CRT)
  1 death214 reports
• VITALIO™ K273

  Implantable pulse generator, pacemaker (non-CRT)
  68 reports
• VITALIO™ K272

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

Recent VITALIO adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker was found to be in safety mode. Technical Services (TS) discussed the settings of the device while in safety mode and recommended replacing the device. Subsequently, this pacemaker was explanted and successfully replaced. No additional adverse patient effects were reported. This pacemaker has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931861 ↗
• MalfunctionSep 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker was found to be in Safety Mode. Technical Services (TS) was consulted and upon data review recommended device replacement. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869114 ↗
• InjurySep 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker reverted into Safety Mode. Subsequently, this pacemaker was successfully explanted and replaced. No additional adverse patient effects were reported outside the revision procedure. At this time, this product has not been returned.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50825858 ↗
• InjurySep 11, 2026Extracardiac stimulation; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: Device Overstimulation of Tissue; Fatigue

  MAUDE report 50741917 ↗
• InjurySep 9, 2026Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697767 ↗
• MalfunctionSep 4, 2026Pacing Problem

  It was reported that this pacemaker was checked by the health care professional (HCP) applying a magnet over it, without observing a change in rate. This could be linked to device in End of Life or safety mode, but neither was not confirmed. The pacemaker remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601120 ↗
• InjuryAug 24, 2026Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem

  It was reported that this pacemaker had entered safety mode, and as a result device changeout was required sooner than expected. Subsequently, 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 50416153 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem; 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 normal battery depletion.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50333763 ↗
• InjuryAug 11, 2026Premature Discharge of Battery

  It was reported that this Pacemaker was found to be in Safety Mode. A request was made to have data from this device analyzed. Data analysis identified potential high impedance within the battery. Technical services (TS) recommended device replacement. The device was subsequently explanted and replaced. No additional adverse patient effects were reported outside of this revision procedure. This product has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50202728 ↗
• InjuryJul 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker was explanted due to Safety Mode and was successfully replaced. No additional adverse patient effects were reported. This device has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50072803 ↗
• InjuryJul 29, 2026Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker entered Safety Mode and had recorded a Code 1003 indicative of battery voltage too low for the projected remaining capacity. Subsequently, it was explanted. A new device was implanted. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50070240 ↗
• InjuryJul 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker device was found to be operating in safety mode. The patient reported symptoms of palpitations with pacing due to unipolar. Subsequently, this device was explanted and successfully replaced. No additional adverse patient effects were reported.

  Patient problems: Palpitations

  MAUDE report 50059190 ↗
• MalfunctionJul 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: Palpitations

  MAUDE report 25897168 ↗
• InjuryJul 7, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER HAD REVERTED TO SAFETY MODE. TECHNICAL SERVICES (TS) WAS CONTACTED AND RECOMMENDED DEVICE REPLACEMENT. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25740448 ↗
• InjuryJun 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH AN IMPLANTABLE PACEMAKER STATED THE DEVICE IS DEAD AND IS CONSIDERING DEVICE REMOVAL. AS OF THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25628241 ↗

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