ADVANTIORecalls & reported problems across all models

We found 3 models of ADVANTIO by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 864 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2016 and Sep 4, 2026 — classified as 2 deaths, 533 injuries, 329 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (169 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 ADVANTIO problems

ADVANTIO models

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

• ADVANTIO™ K063

  Implantable pulse generator, pacemaker (non-CRT)
  2 deaths557 reports
• ADVANTIO™ K064

  Implantable pulse generator, pacemaker (non-CRT)
  253 reports
• ADVANTIO™ K062

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

Recent ADVANTIO adverse event reports

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

• MalfunctionSep 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602395 ↗
• InjuryAug 22, 2026Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker was found to be operating in Safety Mode, which permanently limits device function. Subsequently, this pacemaker was explanted and replaced. This product was received for analysis. No additional adverse patient effects were reported.

  Patient problems: Dyspnea

  MAUDE report 50386380 ↗
• InjuryAug 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker was operating in Safety Mode. Subsequently, this device was explanted and has not been returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50204828 ↗
• InjuryAug 5, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker was found to be in safety mode. Technical Services (TS) recommended device replacement. Two days later, the pacemaker was interrogated and no longer in safety mode. TS still recommended replacing the device despite the device no longer being in safety mode. 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 50148094 ↗
• InjuryJul 27, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this pacemaker reverted to Safety Mode. It was recommended that this device be replaced. The device was subsequently explanted and replaced. No additional adverse patient effects were reported. This product has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50025632 ↗
• MalfunctionJul 21, 2026Off-Label Use

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25899830 ↗
• MalfunctionJul 15, 2026Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) EXHIBITED DIFFICULTIES TO INTERROGATE THIS PACEMAKER. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE AND PERFORMED MULTIPLE DATA AND PROVIDED TROUBLESHOOTING STEPS, INCLUDING REBOOTING THE PROGRAMMER AND ADJUSTING THE TELEMETRY WAND POSITIONING; HOWEVER, THE DEVICE COULD NOT BE READ. THE HEALTHCARE PROVIDER WAS TRANSFERRED TO THE LOCAL REPRESENTATIVE FOR FURTHER ASSISTANCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25833731 ↗
• InjuryMay 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER WAS ADMITTED TO THE EMERGENCY ROOM WHERE THE DEVICE WAS FOUND TO BE ON SAFETY MODE. IT WAS NOTED THAT THE PATIENT EXPERIENCED PALPITATIONS. THIS DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED AND HAS BEEN RETURN FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Palpitations

  MAUDE report 25250428 ↗
• InjuryMay 8, 2026Incorrect, Inadequate or Imprecise Result or Readings; Communication or Transmission Problem

  IT WAS REPORTED THAT THIS PACEMAKER ENTERED INTO SAFETY MODE AND WAS NOT ABLE TO BE INTERROGATED. THE PACEMAKER HAS BEEN EXPLANTED AT THIS TIME AND A NEW PACEMAKER IMPLANTED. ALSO THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AT THE SAME PROCEDURE DUE TO A NON SPECIFIC ALLEGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125138 ↗
• InjuryApr 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE IN SAFETY MODE. THE PATIENT ALSO REPORTED FEELING A BURNING SENSATION AROUND THE IMPLANTED DEVICE. TECHNICAL SERVICES (TS) RECOMMENDED DEVICE REPLACEMENT. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. THIS PACEMAKER HAS NOT BEEN RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Burning Sensation

  MAUDE report 25019404 ↗
• InjuryApr 27, 2026Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER REVERTED TO SAFETY MODE, CAUSING THE PATIENT TO EXPERIENCE A HEART RATE OF 50 BEATS PER MINUTE AS WELL AS FATIGUE DUE TO ABSENCE OF PACING IN THE RIGHT ATRIAL (RA) LEAD CHANNEL. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: Bradycardia; Fatigue

  MAUDE report 25009612 ↗
• InjuryApr 23, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE PACEMAKER WAS SUSPECTED TO EXHIBIT PREMATURE BATTERY DEPLETION WITH A LONGEVITY DROP FROM 1.5 YEARS TO 5 MONTHS WITHIN A SPAN OF 6 MONTHS. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE DEVICE IS DEPLETING NORMALLY. THE BATTERY WAS OUTPERFORMING THE NOMINAL MODEL. THE LONGEVITY HAS EXCEEDED EXPECTATIONS. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THIS PATIENT WITH A PACEMAKER EXPERIENCED A SYNCOPAL EPISODE. THE CAUSE OF THE SYNCOPAL EVENT WAS UNABLE TO BE DETERMINED. IT WAS NOTED THIS PACEMAKER REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). TECHNICAL SERVICES (TS) ANALYZED THE DATA AND NOTED THERE WERE NO OUT OF RANGE MEASUREMENTS. THIS PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: Syncope/Fainting

  MAUDE report 24967594 ↗
• InjuryApr 17, 2026Pacing Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED A 20 SECOND PAUSE WHEN THE PATIENT HAD A SEIZURE. THE DEVICE WAS SHOWING LESS THAN 3 MONTHS OF LONGEVITY REMAINING. TECHNICAL SERVICES (TS) RECOMMENDED DEVICE REPLACEMENT, AND THE PACEMAKER WAS REPROGRAMMED TO PREVENT ENTERING SAFETY MODE. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. THIS PACEMAKER HAS NOT BEEN RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole; Convulsion/Seizure; Syncope/Fainting

  MAUDE report 24913619 ↗
• MalfunctionApr 7, 2026Interrogation Problem

  IT WAS DISCOVERED THAT THIS PACEMAKER WAS UNABLE TO BE INTERROGATED USING A COMMUNICATOR. TECHNICAL SERVICES (TS) WAS CONTACTED AND PROVIDED TROUBLESHOOTING OPTIONS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24805285 ↗
• InjuryMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE IN SAFETY MODE. IT WAS RECOMMENDED THAT THIS DEVICE BE REPLACED. SUBSEQUENTLY THIS PACEMAKER WAS EXPLANTED AND REPLACED. THIS PACEMAKER HAS NOT BEEN RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706581 ↗

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