ADVANTIO™ K064Recalls & reported problems

Summary

The FDA's MAUDE database contains 253 adverse event reports that list this exact device (DI 00802526516719), received between Apr 21, 2016 and Sep 4, 2026 — classified as 219 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (162 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 253 reports, 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 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 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 ↗
• 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 ↗
• MalfunctionMar 15, 2026Nonstandard Device

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601712 ↗
• InjuryMar 12, 2026Incorrect, 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. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED ASSISTANCE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581064 ↗
• InjuryMar 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE IN SAFETY MODE. A DEVICE REPLACEMENT PROCEDURE WAS PERFORMED WHERE THIS PACEMAKER WAS EXPLANTED AND REPLACED WITH A NEW DEVICE SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER WAS RETURNED TO THE FACILITY AWAITING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24576894 ↗
• InjuryMar 11, 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 24571160 ↗
• InjuryFeb 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE PATIENT WITH THIS PACEMAKER EXPERIENCED A SYNCOPAL EPISODE. THIS PATIENT EXPERIENCED BRADYCARDIA. THE DEVICE WAS FOUND TO BE IN SAFETY MODE; BECAUSE OF THIS, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Syncope/Fainting

  MAUDE report 24410963 ↗
• InjuryFeb 13, 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. THIS PRODUCT HAS NOT BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335052 ↗
• InjuryFeb 12, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS OPERATING IN SAFETY MODE, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR DEVICE REPLACEMENT. SUBSEQUENTLY, THE 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 24320219 ↗
• InjuryJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER REVERTED TO SAFETY MODE. TECHNICAL SERVICES WERE CONSULTED AND DEVICE REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, AND DEVICE HAS NOT BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177323 ↗
• InjuryJan 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER REVERTED TO SAFETY MODE. TECHNICAL SERVICES (TS) WAS CONSULTED, AND DEVICE REPLACEMENT WAS RECOMMENDED. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND 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 24145708 ↗
• InjuryJan 16, 2026Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE IN SAFETY MODE, AND AS A RESULT, WAS EXPLANTED AND SUCCESSFULLY REPLACED. ADDITIONALLY, IT WAS SUSPECTED THIS PACEMAKER EXHIBITED PREMATURE BATTERY DEPLETION (PBD). THIS PACEMAKER HAS NOT BEEN RETURNED FOR ANALYSIS AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094520 ↗
• InjuryJan 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE IN SAFETY MODE WHEN THE DEVICE WAS CHECKED PRIOR TO BEING EXPLANTED. THE DEVICE WAS CHECKED AND FOUND THE PATIENT HAD ASYSTOLE WITH PAUSE GREATER THAN 2 SECONDS. THE PATIENT EXPERIENCED SYNCOPE AS WELL. A NEW PACEMAKER WAS IMPLANTED AS REPLACEMENT. THIS PACEMAKER HAS BEEN RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole; Syncope/Fainting

  MAUDE report 24063346 ↗
• InjuryJan 2, 2026Premature Discharge of Battery; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED DUE TO A PRODUCT PERFORMANCE ISSUE. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM THE FIELD INDICATES THIS DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION (PBD). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946149 ↗
• MalfunctionDec 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS FOUND TO BE ON SAFETY MODE. TECHNICAL SERVICES (TS) WAS CONSULTED AND DEVICE REPLACEMENT WAS RECOMMENDED. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809393 ↗