ALTRUA 60Recalls & reported problems across all models

We found 4 models of ALTRUA 60 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,181 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2016 and Sep 4, 2026 — classified as 8 deaths, 822 injuries, 351 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (223 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 ALTRUA 60 problems

ALTRUA 60 models

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

• ALTRUA™ 60 S606

  Implantable pulse generator, pacemaker (non-CRT)
  3 deaths649 reports
• ALTRUA™ 60 S603

  Implantable pulse generator, pacemaker (non-CRT)
  4 deaths272 reports
• ALTRUA™ 60 S602

  Implantable pulse generator, pacemaker (non-CRT)
  1 death148 reports
• ALTRUA™ 60 S601

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

Recent ALTRUA 60 adverse event reports

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

• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this pacemaker was explanted and replaced with a non-Boston Scientific device. No further information was available. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602088 ↗
• InjuryAug 21, 2026Interrogation Problem

  It was reported that this pacemaker was unable to be interrogated. Technical Services (TS) was consulted and noted that the device had indicated approximately two years of remaining longevity in 2022. Based on the available information, TS suspected that the device had reached Battery Capacity Depleted (BCD) status. This device remains in service. No adverse patient effects were reported.Additional information was received from the field stating this patient experienced syncope and a device replacement was performed. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 50376476 ↗
• MalfunctionAug 19, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50329744 ↗
• MalfunctionAug 10, 2026Interrogation Problem

  It was reported that the health care professional (HCP) called Technical Services (TS) for a consult interrogation of this pacemaker system. Troubleshooting efforts were not attempted due to patient left against medical advise. No adverse patient effects were reported. At this time, this pacemaker remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50197050 ↗
• MalfunctionJun 11, 2026Over-Sensing; Data Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED FAR FIELD OVERSENSING ON THE ATRIAL CHANNEL. ADDITIONALLY, TECHNICAL SERVICES (TS) NOTED THAT RIGHT VENTRICULAR (RV) CHANNEL MARKERS WERE NOT VISIBLE ON THE PRESENTING ELECTROGRAM (EGM). NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25479993 ↗
• MalfunctionMay 21, 2026High impedance

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS FOR ITS RIGHT ATRIAL (RA) LEAD DURING ITS SCHEDULED EXPLANT PROCEDURE. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED TROUBLESHOOTING OPTIONS TO TEST THE RA LEAD AND ENSURE ITS INTEGRITY. THIS PACEMAKER WAS EXPLANTED AND REPLACED AS SCHEDULED. THIS DEVICE HAS BEEN RECEIVED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM THE FIELD INDICATES THE RA LEAD WAS PROGRAMMED TO ITS UNIPOLAR PACING VECTOR, WITH THE MEASUREMENTS WITHIN RANGE FOR THIS SETTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243986 ↗
• InjuryMay 8, 2026High impedance; Off-Label Use

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCES IN THE RIGHT ATRIAL (RA) CHANNEL. THE PATIENT WAS NOTED TO HAVE TWO RA LEADS, WITH ONE CONNECTED TO THE RIGHT VENTRICULAR (RV) PORT OF THE DEVICE; HOWEVER, THE HEALTH CARE PROFESSIONAL (HCP) DID NOT CLARIFY WHICH RA LEAD WAS CONNECTED TO THE RV PORT. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED REPLACEMENT IN THE NEAR FUTURE. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THIS ICD WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. OTHER THAN THE INTERVENTION, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129114 ↗
• MalfunctionMay 4, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS UNABLE TO UPLOAD DEVICE DATA. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING OPTIONS. IT WAS SUSPECTED THAT THIS DEVICE HAD TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) SINCE IT WAS IMPLANTED IN 2011. TS RECOMMENDED FURTHER REVIEW WITH A PROGRAMMER. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073402 ↗
• MalfunctionApr 14, 2026Data Problem; Interrogation Problem

  IT WAS REPORTED THAT DURING A CLINIC VISIT, TELEMETRY ISSUES WAS REPORTED WHILE INTERROGATING THIS PACEMAKER. IT WAS NOTED THAT DURING INTERROGATION, THE PACEMAKER DISPLAYED PATIENT HEART RATE TO BE LESS THAN 30 BEATS PER MINUTE (BPM) EVEN THOUGH MARKERS SHOW RATE TO BE AROUND 80 BPM. IT WAS ALSO NOTED THAT THE ELECTROGRAM (EGM) WOULD DROP OUT WHEN A THRESHOLD TEST WAS ATTEMPTED. TECHNICAL SERVICES (TS) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. TS PROVIDED TROUBLESHOOTING RECOMMENDATIONS. AT THIS TIME, THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876170 ↗
• InjuryApr 14, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PACEMAKER WAS ORIGINALLY IMPLANTED BACKWARD. THE FOLLOWING DAY, A REOPERATION WAS PERFORMED AND HAD TO RELOCATE THE DEVICE ON THE PATIENT'S BODY. ON THE NEXT DAY, THE PATIENT UNDERGONE ANOTHER SURGERY ON THE NECK PART DUE TO PLAQUE ACCUMULATION. SUBSEQUENTLY, THIS PACEMAKER WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD) AND REPLACED WITH DIFFERENT MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876102 ↗
• InjuryMar 31, 2026Premature Discharge of Battery; Battery Problem; Data Problem

  IT WAS REPORTED THAT THIS PACEMAKER DELIVERED 11 ATRIAL TACHY RESPONSE (ATR) EPISODES BUT ONLY TWO WERE RECORDED ON THE LOGBOOK. IN ADDITION, IT WAS MENTIONED THAT OVER THE LAST MONTHS THE BATTERY LONGEVITY TIME HAS DECREASED FROM TWO YEARS TO LESS THAN SIX MONTHS REMAINING. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON DATA REVIEW DISCUSSED WITH THE HEALTH CARE PROFESSIONAL (HCP) THE POSSIBILITY THAT THE WRONG TIME AND DATE SETTINGS WERE SELECTED DURING THE RESYNCHRONIZATION OF THE DEVICE. TS INSTRUCTED THE HCP TO RESTART THE LOGBOOK AND RECOMMENDED NORMAL DEVICE FOLLOW UP AND MONITORING. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, TS DISCUSSED THAT THE DEVICE HAS EXCEEDED LONGEVITY EXPECTATION. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE AND HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, THE CONCLUSION CODE UNABLE TO EXCLUDE DEVICE PROBLEM WAS ASSIGNED. ADDITIONAL INFORMATION WAS RECEIVED; THIS PACEMAKER WAS EXPLANTED AND REPLACED AND H

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747659 ↗
• MalfunctionMar 19, 2026Battery Problem; Data Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED A DEVICE INEFFICIENCY DUE TO LOW BATTERY. AS OF THIS TIME, THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639074 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24613974 ↗
• MalfunctionMar 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) INQUIRED ABOUT THE HYPERBARIC OXYGEN THERAPY (HBOT) RATING OF THIS PACEMAKER. TECHNICAL SERVICES (TS) ASSESSED AND INDICATED THAT THE DEVICE MODEL IN QUESTION WAS RATED FOR USE UP TO 5.0 ATMOSPHERES ABSOLUTE (ATA) WHEN FUNCTIONAL. THE HCP INDICATED THAT THE PATIENT STATED THE DEVICE WAS NO LONGER FUNCTIONAL; HOWEVER, DEVICE EXPLANTATION WAS CONSIDERED TOO HIGH RISK. TO DATE, THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608338 ↗
• InjuryFeb 25, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER WENT INTO ATRIAL FIBRILLATION (AF) DUE TO NOISE SIGNALS. THE FIRST AF EVENT OCCURRED AFTER USING ELECTROCAUTERY. CARDIOVERSION WAS UTILIZED. THE DEVICE REMAINS IN SERVICE.

  Patient problems: Atrial Fibrillation

  MAUDE report 24448953 ↗

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