ADVANTIO™ K062Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00802526516658), received between Apr 22, 2016 and Jul 21, 2026 — classified as 33 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2026Off-Label Use

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25899830 ↗
• InjuryNov 26, 2025Adverse 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 A URINARY TRACT INFECTION AND THE DEVICE WAS NEAR DEPLETION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 23660817 ↗
• MalfunctionOct 21, 2025Interrogation Problem; Interrogation Problem

  IT WAS REPORTED BY THE HEALTHCARE PROVIDER THAT THIS PACEMAKER COULDN'T BE INTERROGATED. THE DEVICE HAD BEEN IMPLANTED FOR OVER 10 YEARS, BUT IT WAS UNKNOWN WHETHER THE BATTERY HAD DEPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353517 ↗
• InjuryMar 17, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER DEVICE EXHIBITED UNDERSENSING. SENSING FIXED WAS 2.5 MILLI VOLTS OUTPUT. AS OF THIS TIME, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THIS PACEMAKER WAS EXPLANTED, REPLACED AND WAS RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618085 ↗
• InjuryFeb 18, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER SYSTEM PRESENTED TO THE EMERGENCY ROOM (ER) AFTER A SYNCOPAL EPISODE. REVIEW OF THE PRESENTING ELECTROGRAM (EGM) SUGGESTED THE PACEMAKER WAS OPERATING AS PROGRAMMED, HOWEVER THE HEALTH CARE PROFESSIONAL (HCP) STATES LOSS OF CAPTURE (LOC) WAS OBSERVED ON THE MONITOR WITH NO ASSOCIATED SYMPTOMS REPORTED. ADDITIONALLY, TWO NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) WERE STORED AND APPEARED TO CONTAIN NOISE, BUT HAD OCCURRED AFTER THE TIME OF THE SYNCOPAL EPISODE. THE MOST RECENT AUTO THRESHOLD TEST WAS 1.2V @ 0.4 MS. FURTHER DEVICE/LEAD TESTING WAS ADVISED. THIS PACEMAKER SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED, AND THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED DURING THE SAME PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393574 ↗
• InjuryOct 15, 2024Signal Artifact/Noise; Failure to Capture; Over-Sensing; Signal Artifact/Noise; Failure to Capture; Over-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED NOISE THAT WAS OVERSENSED AS WELL AS LOSS OF CAPTURE (LOC) ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL. THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD IS A NON-BOSTON SCIENTIFIC AND TECHNICAL SERVICES (TS) RECOMMENDED TROUBLESHOOTING TO ASSESS LEAD INTEGRITY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451654 ↗
• InjuryOct 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER WAS EXPLANTED DUE TO UNKNOWN ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436503 ↗
• MalfunctionApr 16, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS SYSTEM WITH A PACEMAKER AND A RIGHT VENTRICULAR (RV) LEAD SHOWED POSSIBLE LOSS OF CAPTURE (LOC) ON A BEAT AT THE PRESENTING ELECTROGRAM (EGM) AS DID NOT SHOW A CLEAR T WAVE AFTER IT. ALL OTHER PRESENTING STRIPS THAT WERE REVIEWED HAD OBVIOUS T WAVES AFTER ALL PACED AND SENSED COMPLEXES. THERE WERE TIMES WHERE THE PACED COMPLEX LOOKED LIKE A SENSED BEAT, AND IT WAS SUSPECTED THERE WAS SOME FUSION ON THOSE BEATS. THE PACEMAKER AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113686 ↗
• InjuryJan 17, 2024Adverse 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 BACTEREMIA AND ENDOCARDITIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS PACEMAKER WAS EXPLANTED.

  Patient problems: Bacterial Infection; Endocarditis

  MAUDE report 18525676 ↗
• MalfunctionMay 19, 2023Failure to Capture; Over-Sensing; Pacing Problem; Failure to Capture; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED OVERSENSING OF A MINUTE VENTILATION (MV) ARTIFACT ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE OVERSENSING LEAD TO PACING INHIBITION OF ROUGHLY 2 SECONDS. SIGNAL ARTIFACT MONITORING (SAM) STORED AN EPISODE OF THIS EVENT AND DISABLED THE MV FEATURE. A REVIEW OF THE REPORTS NOTE LOSS OF CAPTURE, AS WELL. TECHNICAL SERVICES (TS) PROVIDED POSSIBLE CAUSES OF THIS ISSUE AND PROVIDED RESOLUTION RECOMMENDATIONS. THE DEVICE REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 16961191 ↗
• InjuryFeb 13, 2023Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND HIGH, OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS OF GRATER THAN 2500 OHMS. A SIGNAL ARTIFACT MONITOR (SAM) EVENT OCCURRED EARLIER THAN THE REPORTED NOISE AND HIGH IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR A REVIEW. IT WAS NOTED BY THE FIELD REPRESENTATIVE THAT THE PATIENT HAD EXPERIENCED A FALL THAT MONTH AS WELL, WONDERING IF THAT COULD BE CORRELATED. TS DISCUSSED THE POSSIBLE OPTIONS. THE DEVICE WAS TURNED OFF, SURGICALLY ABANDONED AND A NON-BOSTON SCIENTIFIC DEVICE WAS ADDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fall

  MAUDE report 16364042 ↗
• InjuryNov 17, 2022Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER EXHIBITED FAILURE TO CAPTURE AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR CHANNEL. DUE TO THIS, A LEAD SAFETY SWITCH WAS TRIGGERED. IT WAS DETERMINED THAT THIS WAS DUE TO A RIGHT VENTRICULAR LEAD FRACTURE. FURTHERMORE, THE PATIENT EXPERIENCED A BRADYCARDIA EPISODE. A PROCEDURE WAS PERFORMED IN ORDER TO SURGICALLY ABANDON AND REPLACE THE LEAD. DURING THIS PROCEDURE IT WAS DECIDED TO ALSO REPLACE THE DEVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 15820824 ↗
• InjuryOct 12, 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 15586421 ↗
• InjurySep 15, 2022Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE IN SAFETY MODE. THERE WERE CONCERNS THAT THIS DEVICE WAS DEPLETED PREMATURELY. THE PATIENT WAS BROUGHT TO THE HOSPITAL WITH BRADYCARDIA. A REVISION PROCEDURE WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 15427284 ↗
• MalfunctionMay 25, 2022Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXPERIENCED DIFFICULTY BEING INTERROGATED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASSISTED THE HEALTH CARE PROFESSIONAL (HCP) WITH TROUBLESHOOTING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED AN XRAY. THE FIELD REPRESENTATIVE (REP) WAS GOING TO ATTEMPT TO INTERROGATE WITH A DIFFERENT COMPANY'S PROGRAMMER. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED FROM THE REP. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14493656 ↗
• InjuryApr 28, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PACEMAKER WAS EXPLANTED DUE TO BATTERY REPLACEMENT. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14230619 ↗
• InjuryApr 20, 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 14164827 ↗
• MalfunctionMar 5, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WERE NO FIELD ALLEGATIONS MADE AGAINST THE PERFORMANCE OF THIS PACEMAKER DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED WITH THE REASON FOR REPLACEMENT REPORTED AS NORMAL BATTERY DEPLETION. THE DEVICE WAS RETURNED, AND DEVICE ANALYSIS WAS COMPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13677598 ↗
• InjuryJan 2, 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 WITH SEPSIS. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 13138621 ↗
• MalfunctionOct 17, 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 DEVICE DID NOT MEET LONGEVITY EXPECTATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12644220 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Sepsis; Unspecified Infection

  MAUDE report 11182006 ↗
• MalfunctionJan 2, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER DEVICE EXHIBITED PREMATURE BATTERY DEPLETION BEHAVIOR. BOSTON SCIENTIFIC ENGINEERING ANALYSIS OF DEVICE DATA CONFIRMED THAT THE POWER CONSUMPTION OF THIS DEVICE HAS BEEN INCREASING IN A GRADUAL FASHION. THE ANALYSIS ALSO INDICATED THAT BASED ON CONSERVATIVE MODELING, THE DEVICE WILL NOT DEPLETE TO THE ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS BEFORE THE 90 DAY ERI TO END OF LIFE (EOL) TIME. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) PROVIDED THE ANALYSIS RESULTS TO THE HEALTHCARE PROVIDER (HCP) AND INDICATED THEY WILL SEND A MESSAGE TO THE LOCAL BOSTON SCIENTIFIC REPRESENTATIVE (REP). THE DEVICE REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11105064 ↗
• MalfunctionDec 18, 2020Signal Artifact/Noise; Over-Sensing; Defective Device; Device Sensing Problem; Signal Artifact/Noise; Over-Sensing; Defective Device; Device Sensing Problem

  IT WAS REPORTED THAT THIS PACEMAKER AND A NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD EXHIBITED THRESHOLD MEASUREMENT ISSUES. THE LAST MEASURED THRESHOLD MEASUREMENT WAS ABOVE THE OUTPUTS. THERE WERE TWO BEATS OF LOSS OF CAPTURE NOTED. ADDITIONALLY, THERE WERE STORED EPISODES OF RV NOISE, OVERSENSING, AND GREATER THAN TWO SECONDS OF PACING INHIBITION. FURTHER, TECHNICAL SERVICES (TS) NOTED EPISODES OF NOISE WHICH WERE RELATED TO THE MINUTE VENTILATION (MV) FEATURE, BUT THIS NOISE WAS NOT BEING OVERSENSED. IT WAS DISCUSSED WITH THE HEALTH CARE PROFESSIONAL (HCP) THAT THIS RV LEAD SHOULD BE EVALUATED, AND THE HCP WAS GOING TO DISCUSS FURTHER WITH THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11042432 ↗
• MalfunctionJul 21, 2020Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  THIS PACEMAKER AND ANOTHER MANUFACTURER'S LEADS EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS, HIGH THRESHOLDS AND LOSS OF CAPTURE. TECHNICAL SERVICES DISCUSSED DEVICE DATA AND NO FURTHER INTERVENTION NEEDED AT THIS TIME. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10306107 ↗
• InjuryJul 6, 2020Adverse 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10234032 ↗