VITALIO™ K272Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00802526516955), received between Apr 22, 2016 and Jun 25, 2026 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (2 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryDec 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER HAD REVERTED TO SAFETY MODE. TECHNICAL SERVICES (TS) WAS CONSULTED, DISCUSSED SAFETY MODE PARAMETERS, AND RECOMMENDED DEVICE REPLACEMENT. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED DETAILED THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694168 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SYSTEM WAS EXPLANTED DUE TO THE PATIENT FELT DISCOMFORT. ACCORDING TO THE PATIENT HE FELT THE DEVICE AROUND HIS ABDOMEN MORE THAN BEFORE. A NEW LEADLESS SYSTEM WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 19270280 ↗
• MalfunctionNov 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER DEVICE WAS FOUND IN SAFETY MODE. TECHNICAL SERVICES (TS) RECOMMENDED TO HAVE THE DEVICE REPLACED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230077 ↗
• MalfunctionSep 20, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS PATIENT WITH THIS PACEMAKER DEVICE EXHIBITED T WAVE OVERSENSING SINCE LAST FEW MONTHS NOW. THE PATIENT HAD HISTORY OF RAPID VENTRICULAR RESPONSE (RVR) AND NON-SUSTAINED EPISODES WERE NOTED ON THE PRESENTING. UPON FURTHER REVIEW OF THE EPISODES, IT LOOKED LIKE INTERMITTENT T WAVE OVERSENSING. TECHNICAL SERVICES (TS) DISCUSSED OPTIONS FOR OPTIMIZING SENSITIVITY, RETRACTOR AS MUCH AS POSSIBLE TO MINIMIZE TWOS AND OPTION OF ADJUSTING TACHY DETECTION AS APPROPRIATE. THIS DEVICE REMAINS IN SERVICE, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17780863 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER DEVICE UNDERWENT A REVISION. THE PATIENT WAS FEELING THE EDGE OF THE DEVICE. MOREOVER, THE DEVICE WAS REPOSITIONED FROM SUBCUTANEOUS TO SUBMUSCULAR. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243467 ↗
• MalfunctionJan 22, 2019High impedance; Pacing Problem; High impedance; Pacing Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED HIGH, OUT-OF-RANGE PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) CHANNEL WHICH CAUSED A LEAD SAFETY SWITCH. PACING INHIBITION OF GREATER THAN TWO SECONDS WAS ALSO NOTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8268539 ↗
• InjuryOct 22, 2018Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THE PACEMAKER WAS EXPLANTED AND THEN WAS USED AS AN EXTERNAL TEMPORARY PACEMAKER. SUBSEQUENTLY, THE PACEMAKER WAS REMOVED FROM SERVICE WHEN A NEW SYSTEM WAS IMPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 7989902 ↗
• MalfunctionOct 9, 2017High impedance; Device Sensing Problem; High impedance; Device Sensing Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER EXHIBITED VARYING IMPEDANCES BETWEEN 600-700 OHMS AND 1,500 OHMS. THE THRESHOLDS ARE STABLE; HOWEVER, THE P-WAVE AMPLITUDES ARE NOT AS EXPECTED. IT WAS STATED THAT THE PATIENT WILL CONTINUE TO BE FOLLOWED CLOSELY. THE PATIENT'S RIGHT ATRIAL (RA) LEAD IS A NON-BOSTON SCIENTIFIC PRODUCT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN-SERVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6932138 ↗
• InjuryApr 19, 2017Premature Discharge of Battery; Low impedance; Premature Discharge of Battery; Low impedance

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND ASSOCIATED LEAD DISPLAYED LOW PACE IMPEDANCE MEASUREMENTS. THE DEVICE WAS NOTED TO HAVE EXPERIENCED PREMATURE BATTERY DEPLETION. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE DEVICE WAS EXPLANTED AND THE LEAD WAS ABANDONED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6503982 ↗
• InjuryJul 16, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 5800152 ↗
• InjuryJul 14, 2016Failure to Capture; Failure to Capture

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE. AN INVASIVE PROCEDURE WAS PERFORMED. THIS LEAD WAS EXPLANTED AND REPLACED. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5795685 ↗
• MalfunctionJul 12, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S REMOTE HOME MONITORING SYSTEM DISPLAYED A RED BLINKING LIGHT, INDICATIVE OF A POTENTIAL CHANGE IN THEIR DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5787444 ↗
• InjuryApr 22, 2016Failure to Capture; Pacing Problem; Ambient Noise Problem; Failure to Capture; Pacing Problem; Ambient Noise Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER EXHIBITED NOISE AND PACING INHIBITION. THERE WAS ASYSTOLE GREATER THAN 2 SECONDS. IT WAS SUSPECTED THAT THERE WAS A LEAD FRACTURE ON THE RIGHT ATRIAL (RA) COMPETITOR LEAD. A PROCEDURE WAS PERFORMED TO EXPLANT THE LEAD AT WHICH TIME A LEAD FRACTURE WAS CONFIRMED ON THE LEAD NEAR THE POCKET. DURING THE PROCEDURE, THERE WAS PACING INHIBITION WHILE THE DEVICE WAS IN CAUTERY MODE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE PACING INHIBITION WAS LIKELY DUE TO THE EXPOSED FRACTURE BEING NEAR THE CAUTERY. THE FRACTURED LEAD WAS SURGICALLY ABANDONED. THE DEVICE WAS ALSO EXPLANTED AND REPLACED WITH AN UPGRADED DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Arrest; Dizziness

  MAUDE report 5601741 ↗