VITALIO™ K273Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00802526516962), received between Apr 22, 2016 and Sep 4, 2026 — classified as 44 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (14 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 68 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryOct 27, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED BATTERY STATUS HIGH IMPEDANCE AND HYDROGEN. TS ADDED THAT THE PATIENT SHOULD CONTINUE TO KEEP NORMAL DOCTOR APPOINTMENTS. DEVICE REPLACEMENT WAS RECOMMENDED. THIS PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389573 ↗
• MalfunctionAug 6, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PACEMAKER LONGEVITY DROPPED FROM 2 YEARS TO 7 MONTHS REMAINING IN A SPAN OF 6 MONTHS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22732967 ↗
• InjuryJun 9, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. TECHNICAL SERVICES (TS) SUGGESTS DEVICE REPLACEMENT AS SOON AS POSSIBLE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THIS DEVICE WAS EXPLANTED. A NEW IMPLANTABLE PACEMAKER WITH A DIFFERENT MODEL WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172981 ↗
• InjuryFeb 12, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER DEVICE WAS SUSPECTED TO BE DRAINING QUICKER THAN EXPECTED AS DEVICE HAS DEPLETED FROM 2 YEARS TO 5 MONTHS BATTERY REMAINING IN A SPAN OF 1 MONTH AS PER CURRENT CHECKED. PATIENT WAS CHECKED IN PERSON AND THERE WAS NO OBSERVATION OF EXTRA BATTERY DRAINING WITH 89 PERCENT POWER CONSUMPTION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASSESSED AND STATED THAT A CORRECTION HAPPENED THAT PROJECTING BASED ON VOLTAGE. AS OF THIS TIME, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION (NBD). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364765 ↗
• InjuryJan 10, 2025Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER SYSTEM PRESENTED THE EMERGENCY ROOM (ER) WITH SYNCOPE, FAINTING/LOSS OF CONSCIOUSNESS, AND A HEART RATE OF 38 BEATS PER MINUTE (BPM). CONSULT INTERROGATION WAS UNSUCCESSFUL, HOWEVER IT WAS LATER DETERMINED THAT THIS PACEMAKER HAD ENTERED STORAGE MODE. ADDITIONALLY, THE SCREEN DISPLAYED A MESSAGE STATING "VOLTAGE TOO LOW FOR REMAINING CAPACITY." THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND EXTERNAL PACING WAS APPLIED DUE TO PACING INHIBITION. THIS PACEMAKER REMAINS IN SERVICE, HOWEVER DEVICE CHANGEOUT WAS ANTICIPATED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PRODUCT RETURN WAS REQUESTED.

  Patient problems: Bradycardia; Loss of consciousness; Syncope/Fainting

  MAUDE report 21129824 ↗
• MalfunctionSep 2, 2024Over-Sensing; Pacing Problem; Battery Problem; Over-Sensing; Pacing Problem; Battery Problem

  IT WAS REPORTED THAT THE PROJECTED LONGEVITY FOR THIS PACEMAKER DECREASED FROM ONE AND HALF YEARS TO LESS THAN THREE MONTHS IN A SIX-MONTH PERIOD. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THAT THE MINUTE VENTILATION (MV) HAD BEEN TURNED OFF AND WAS NOW TURNED BACK ON ALONG WITH SIGNAL ARTIFACT MONITORING (SAM). AN ANALYSIS OF DEVICE DATA NOTED THAT THE CHANGE IN LONGEVITY WAS UNRELATED TO MV AND SAM AND NOTED THERE IS NO EVIDENCE OF PREMATURE BATTERY DEPLETION (PBD), HOWEVER THE BATTERY IS BEHAVING FAR FROM PREDICTIONS. TS RECOMMENDED A DEVICE REPLACEMENT. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20118232 ↗
• InjuryAug 28, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY LONGEVITY OF THIS IMPLANTABLE PACEMAKER INDICATED 2 YEARS REMAINING A YEAR AGO, AND RECENTLY SHOWED LESS THAN 3 MONTHS REMAINING. BOSTON SCIENTIFIC TECHNICAL SERVICE (TS) REVIEWED WITH HEALTHCARE PROFESSIONAL (HCP) AND DISCUSSED THAT THERE WERE NO CHANGES IN OUTPUT AND THRESHOLD AND WITH ATRIAL FIBRILLATION (AF) BURDEN AT LESS THAN 1 PERCENT. TS ALSO CONFIRMED WITH HCP THAT THIS DEVICE HAS LOW CONSUMPTION VALUES. FURTHERMORE, TS EXPLAINED THIS IT COULD BE VOLTAGE WAS HIGHER THAT THE HARDWARE BASED PROJECTED LONGEVITY OR WAS OVERACHIEVING AND ADVISED ENGINEERING ANALYSIS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20088194 ↗
• InjuryAug 23, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM IS APPROVED FOR MAGNETIC RESONANCE IMAGING (MRI). HOWEVER, IT WAS NOTED THAT THEY PERFORMED AN MRI. POST-MRI THE TECHNICIAN INDICATES THAT THE OLD LEADS FRAYING AND THE WIRES ARE POKING THROUGH THE INSULATION. THE PATIENT WAS REFERRED TO THEIR CLINIC DUE TO THE STATEMENTS MENTIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED RELATED TO THE OFF-LABEL USE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED AND ONE PART OF ONE OF THE LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20047134 ↗
• InjuryJun 10, 2024Telemetry Discrepancy; Telemetry Discrepancy

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED INVALID RADIOFREQUENCY OVERUSE CONDITION. FURTHER INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 19506404 ↗
• InjuryMay 8, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER BATTERY LONGEVITY WAS DEPLETING RAPIDLY. ADDITIONALLY, PATIENT IS PACEMAKER DEPENDENT. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270253 ↗
• MalfunctionFeb 20, 2024Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS DEVICE EXPERIENCED DIFFICULTY BEING INTERROGATED. THE PROGRAMMER WAND WAS HOVERED OVER THIS DEVICE AND THE GREEN LIGHT ON THE WAND FLASHED HOWEVER STILL UNABLE TO READ THE DEVICE. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING WITH THE HEALTH CARE PROFESSIONAL (HCP) INCLUDING MOVING THE PATIENT AWAY FROM MONITORS AND REMOVING ELECTRODES FROM THEIR CHEST WHICH WAS UNSUCCESSFUL. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE FIELD. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741911 ↗
• InjuryJan 31, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAS DROPPED FROM 1.5 YEARS DOWN TO 5 MONTHS BATTERY REMAINING IN A SPAN OF 2 MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASSESSED THAT DEVICE WENT FROM 39 MICRO WATTS TO 44 MICRO WATTS. ALSO, STATED THAT THIS WAS MOST LIKELY THE TRANSITION FROM COULOMETER TO VOLTAGE BASED CALCULATION. MOREOVER, DURING THE LAST YEAR OF DEVICE LONGEVITY, THE DEVICE SWITCHED FROM MONITORING POWER CONSUMPTION TO VOLTAGE BASED PROJECTION. THIS CAN RESULT IN A DROP IN BATTERY LONGEVITY. AS OF THIS TIME, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED WHICH INDICATED THAT THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612713 ↗
• InjuryJan 5, 2024Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION (PBD). THE DEVICE BATTERY LONGEVITY DROPPED FROM ONE YEAR TO FOUR MONTHS IN A SPAN OF SIX MONTHS. THIS DEVICE WAS SURGICALLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451020 ↗
• MalfunctionSep 28, 2023Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM EXHIBITED OVERSENSING AND NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND A FOLLOW UP WITH CARDIOLOGY WAS RECOMMENDED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE HAS BEEN EXPLANTED DUE TO THERAPY UPGRADE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17831125 ↗
• InjuryAug 4, 2023Low impedance; Low impedance

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED LOW OUT OF RANGE PACING IMPEDANCE ON THE RIGHT ATRIAL (RA) CHANNEL. THE CAUSE OF THE LOW OUT OF RANGE IMPEDANCE IS UNKNOWN. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17459419 ↗
• InjuryApr 7, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER PRESENTED IN A SYNCOPAL STATE. THE HEART RATE WENT DOWN. THE PACEMAKER WAS REQUESTED TO BE INTERROGATED AND REMAINS IN SERVICE AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Syncope/Fainting

  MAUDE report 16698848 ↗
• MalfunctionOct 3, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT TECHNICAL SERVICES (TS) WAS CONTACTED TO DISCUSS PROGRAMMING OPTIONS FOR THE PATIENTS MINUTE VENTILATION (MV) AND ACCELEROMETER RATE RESPONSE. THE PATIENT'S HEARTRATE WAS SOMETIMES INCREASING TOO QUICKLY AND SOMETIMES NOT AT ALL. TS DISCUSSED THE RATE RESPONSE SETTINGS AND MADE PROGRAMMING RECOMMENDATIONS. THE DEVICE AND LEADS REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15534181 ↗
• MalfunctionSep 29, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A MESSAGE WAS RECORDED ON THIS PACEMAKER INDICATING VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY. TECHNICAL SERVICES (TS) SUSPECTED THE DEVICE WAS BEYOND END OF LIFE (EOL), SINCE IT HAS BEEN IMPLANTED FOR EIGHT YEARS. PATIENT HAS NO REMOTE MONITORING. TS RECOMMENDED EXPLANT THE DEVICE AS IT IS IN STORAGE MODE. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505750 ↗
• InjurySep 20, 2022Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) FOR A HEART RATE OF 20 BEATS PER MINUTE (BPM) AND WENT INTO CARDIAC ARREST. THIS PACEMAKER COULD NOT BE INTERROGATED AND HAD NO RESPONSE TO A MAGNET DUE TO BATTERY DEPLETION. A X-RAY WAS PERFORMED TO CONFIRM DEVICE INFORMATION. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED THEN REPLACED WITH A NEW PACEMAKER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 15457599 ↗
• InjuryJul 27, 2022Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER EXHIBITED FAILURE TO CAPTURE ON THE RIGHT VENTRICULAR CHANNEL. THIS DEVICE WAS EXPLANTED AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15117473 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Pocket Erosion; Sepsis; Unspecified Infection

  MAUDE report 14690610 ↗
• MalfunctionAug 3, 2021Defective Device; Defective Device

  THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE WAS ANALYZED, AND THE PRODUCT INVESTIGATION RESULT INDICATED THAT THIS DEVICE EXHIBITED CHRONIC HIGH ATRIAL SENSING WHICH AFFECTED THE LONGEVITY.

  Patient problems: Insufficient Information

  MAUDE report 12271293 ↗
• MalfunctionJul 13, 2021Defective Device; Defective Device

  THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE WAS ANALYZED AND THE PRODUCT INVESTIGATION RESULT INDICATED THAT THIS DEVICE EXHIBITED CHRONIC HIGH ATRIAL SENSING WHICH AFFECTED THE LONGEVITY.

  Patient problems: Insufficient Information

  MAUDE report 12164000 ↗
• InjuryJul 8, 2021False Positive Result; Failure to Read Input Signal; False Positive Result; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS PATIENT WITH A PACEMAKER PRESENTED TO THE EMERGENCY ROOM (ER) DUE TO SYNCOPE. TECHNICAL SERVICES REVIEW THE REPORT AND FOUND THERE WAS LOW ATRIAL INTRINSIC AMPLITUDE HOWEVER, THERE WAS NO OVERSENSING OBSERVED. ADDITIONALLY, THERE WAS A STORED SIGNAL ARTIFACT MONITORING (SAM) EPISODE IN WHICH THE MINUTE VENTILATION (MV) SENSOR WAS DISABLED AND HAS NOT BEEN TURNED BACK ON. THE SAM EPISODE APPEARS TO BE FALSE DUE TO ATRIAL FIBRILLATION. THE PACEMAKER DID RECORD AN EPISODE IN THE LAST 72 HOURS HOWEVER, THE CAUSE THE SYNCOPE IS UNKNOWN. AT THIS TIME, THE PACEMAKER REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 12139513 ↗