VITALIO™ K274Recalls & reported problems

Summary

The FDA's MAUDE database contains 214 adverse event reports that list this exact device (DI 00802526536557), received between Jul 14, 2016 and Sep 29, 2026 — classified as 1 death, 192 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (133 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 214 reports, 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 ↗
• 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 16, 2026Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  IT WATS REPORTED THAT PATIENT INITIATED INTERROGATION (PII) OF THIS PACEMAKER WAS UNSUCCESSFUL, AND THE LAST SUCCESSFUL DEVICE TRANSMISSION WAS NEARLY 1.5 MONTHS AGO. A DEVICE EVALUATION FROM (B)(6) 2026 REVEALED A BATTERY LONGEVITY ESTIMATE OF 1.5 YEARS REMAINED AT THAT TIME. WHILE TROUBLESHOOTING THE COMMUNICATOR INTERROGATION ISSUE, THE PATIENT'S LANDLINE CONNECTION WAS REPLACED WITH A CELLULAR ADAPTER, AND PIIS WERE ATTEMPTED IN THE BEDROOM AND LIVING ROOM. DURING THESE ATTEMPTS, TWO TO THREE COLLECTING WAVES WERE OBSERVED. A REQUEST WAS MADE TO HAVE REMOTE MONITORING DATA FROM THIS DEVICE ANALYZED. BASED ON THE MULTIPLE PII ATTEMPTS, IT WAS SUSPECTED THAT THE DEVICE HAD EXCEEDED THE WEEKLY MAXIMUM OF PIIS. IT WAS LATER CONFIRMED THAT ENVIRONMENTAL INTERFERENCE HAD OCCURRED THAT DAY OF PII ATTEMPTS. THE NEXT DAY, SUCCESSFUL COMMUNICATOR INTERROGATION REVEALED THAT THE PACEMAKER WAS OPERATING IN SAFETY MODE. PROGRAMMER INTERROGATION CONFIRMED THE DEVICE WAS OPERATING AS PROGRAMMED AND THERE WAS 1.5 YEARS REMAINING ON THE BATTERY. THE FOLLOWING MONTH, THIS PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PRODUCT RETURN WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25526647 ↗
• InjuryMay 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS OPERATING IN SAFETY MODE. SUBSEQUENTLY, THIS PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, AND IT WAS NOTED THAT THE PATIENT WAS PACER DEPENDENT. PRODUCT RETURN WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25310969 ↗
• InjuryMay 8, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER HAD REVERTED TO SAFETY MODE. SUBSEQUENTLY THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. OTHER THAN THE INTERVENTION NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS BEEN RETURNED FOR ANALYSIS; HOWEVER, RESULTS OF INVESTIGATION HAVE NOT BEEN COMPLETED AT TIME OF SUBMISSION OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE RESULTS OF INVESTIGATION BECOME AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128434 ↗
• InjuryApr 29, 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 ANOMALY. A NEW DEVICE WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25030087 ↗
• InjuryApr 23, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER HAD REVERTED TO SAFETY MODE. THIS PACEMAKER WAS SUBSEQUENTLY EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974103 ↗
• InjuryApr 20, 2026High impedance

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. SUBSEQUENTLY, THIS PACEMAKER WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932891 ↗
• InjuryApr 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE IN SAFETY MODE. DEVICE REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, THIS PACEMAKER WAS EXPLANTED AND REPLACED. THIS PACEMAKER WAS RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24913664 ↗
• MalfunctionApr 8, 2026Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS UNABLE TO BE INTERROGATED USING A PROGRAMMER. UPON FURTHER EXAMINATION, THE DEVICE WAS FOUND TO HAVE ENTERED SAFETY MODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THE DEVICE SHOULD BE REPLACED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817822 ↗
• InjuryMar 11, 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 ANOMALY. ANOTHER PACEMAKER WAS IMPLANTED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE PROVIDED THE PACEMAKER WAS FOUND TO BE IN SAFETY MODE PRIOR TO EXPLANT. THIS PACEMAKER HAS NOT BEEN RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569188 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PACEMAKER DISPLAYED A RED CALL DOCTOR ALERT FOR UNKNOWN REASONS. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536593 ↗
• MalfunctionFeb 24, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT TECHNICAL SERVICES (TS) REVIEWED THE DATA OF THIS PACEMAKER WITH THE HEALTH CARE PROFESSIONAL (HCP). UPON REVIEW, IT WAS REPORTED THAT THIS PACEMAKER RECORDED A PACEMAKER MEDIATED TACHYCARDIA (PMT) EPISODE WHICH WAS TERMINATED BY THE PMT ALGORITHM. ADDITIONALLY, THIS PACEMAKER RECORDED INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES DUE TO FAR-FIELD OVERSENSING. IT WAS NOTED THE PATIENT WOULD FOLLOW UP IN AN OUTPATIENT SETTING FOR FURTHER EVALUATION. THIS PACEMAKER REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428748 ↗
• InjuryFeb 18, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER REVERTED TO SAFETY MODE. TECHNICAL SERVICES (TS) DISCUSSED THAT THERE WAS NO PROGRAMMING AND NO MAGNET RESPONSE. TS RECOMMENDED DEVICE REPLACEMENT DUE TO THE INCREASE IN POWER CONSUMPTION DUE TO AN INCREASE IN PACING OUTPUT VOLTAGE. CURRENTLY, THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377833 ↗