ALTRUA 40Recalls & reported problems across all models

We found 3 models of ALTRUA 40 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Apr 25, 2016 and Sep 9, 2026 — classified as 1 death, 50 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (15 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 40 problems

ALTRUA 40 models

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

• ALTRUA™ 40 S404

  Implantable pulse generator, pacemaker (non-CRT)
  33 reports
• ALTRUA™ 40 S403

  Implantable pulse generator, pacemaker (non-CRT)
  1 death27 reports
• ALTRUA™ 40 S401

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

Recent ALTRUA 40 adverse event reports

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

• InjurySep 9, 2026Adverse 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 50695463 ↗
• InjuryJan 26, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178264 ↗
• InjuryJan 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER DISPLAYED AN ERROR MESSAGE AND DEVICE REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24135317 ↗
• MalfunctionDec 23, 2025Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAS BEEN IMPLANTED FOR OVER 15 YEARS. THE DEVICE STILL HAS BATTERY REMAINING BUT IS UNABLE TO BE INTERROGATED. AT THIS TIME THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION OBTAINED, THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION (NBD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881933 ↗
• MalfunctionDec 31, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER WAS OVERSENSING NOISE DURING INTERROGATION AT A FOLLOW-UP APPOINTMENT. TECHNICAL SERVICES (TS) REVIEWED PROVIDED ELECTROGRAM (EGM) AND DETERMINED THAT THE NOISE WAS CAUSED BY TELEMETRY. IT WAS ADVISED TO STABILIZE THE PROGRAMMER WAND OVER THE PACEMAKER CAN PROPERLY. IT WAS RESOLVED AFTER TROUBLESHOOTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048177 ↗
• InjuryJan 29, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAS DEPLETED FROM 2.5 YEARS DOWN TO 0.5 YEARS BATTERY REMAINING DURING THE RECENT CHECKED. PATIENT IS VERY DEPENDENT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED CHANGES IN BATTERY COULD BE DUE TO ROUNDING UP AND DOWN AT THE CHECKS. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595198 ↗
• InjuryAug 24, 2023Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER EXHIBITED RAPID BATTERY DEPLETION FROM 2.5 YEARS TO END OF LIFE (EOL) IN A SPAN OF THREE MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED REASONS FOR RAPID BATTERY DEPLETION. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THIS DEVICE WAS SURGICALLY EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17610450 ↗
• InjuryAug 1, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER HAD LONGEVITY OF SIX MONTHS DROPPED TO END OF LIFE (EOL) IN A SPAN OF FOUR MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED HOW THE DEVICE MANAGES LONGEVITY IN RELATION TO CURRENT BINS AND COULD HAVE BEEN THIS DEVICE WAS OPERATING IN A LOWER CURRENT BUT ON THE EDGE OF IT. ALSO, SOME SMALL CHANGE IN THE VARIABLES THAT IMPACT LONGEVITY CAUSING THE DEVICE TO OPERATE IN A HIGHER CURRENT BIN PUSHING THE DEVICE TO ERI. THIS DEVICE WILL BE CHANGED OUT. ADDITIONAL INFORMATION INDICATED THAT THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434708 ↗
• InjuryDec 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. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 15975997 ↗
• InjuryOct 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 15526245 ↗
• InjuryJun 9, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER WAS ADMITTED TO THE HOSPITAL DUE TO CONGESTIVE HEART FAILURE AND SEVERE NECK PAIN. WHILE IN THE HOSPITAL, A PACEMAKER CHECK WAS PERFORMED. DURING PACE THRESHOLD TESTING, THE PATIENT WENT RIGID, THEIR LIMBS SPASMED, AND THE PATIENT WAS UNABLE TO SPEAK FOR SEVERAL MINUTES. IT WAS THOUGHT THAT THE TEST APPEARED TO STOP THE PATIENT'S HEARTBEAT. THE TEST WAS CANCELLED AND THE PATIENT RECOVERED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL SEVERAL DAYS LATER AND WAS PLACED ON HOSPICE CARE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

  Patient problems: Cardiac Arrest; Cramp(s) /Muscle Spasm(s); Loss of consciousness; Syncope/Fainting

  MAUDE report 14644430 ↗
• MalfunctionJun 7, 2022Battery Problem; Impedance Problem; Battery Problem; Impedance Problem

  IT WAS REPORTED THAT THIS PACEMAKERS LONGEVITY IN NOVEMBER WAS 1.5 YEARS AND THEN 6 MONTHS LATER IT WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). ADDITIONALLY, IT WAS NOTED THEY WERE UNABLE TO OBTAIN IMPEDANCE MEASUREMENTS HOWEVER, DAILY MEASUREMENTS WERE PRESENT. AMPLITUDES AND THRESHOLDS WERE WITHIN NORMAL RANGE. AT THIS TIME, THE PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622700 ↗
• InjuryJun 3, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A FAULT CODE MESSAGE DISPLAYED ON THE PROGRAMMER WHILE INTERROGATING THE PACEMAKER. THE PATIENT EXPERIENCED A VERY BRIEF PRE-SYNCOPE DURING THE SESSION. THE DEVICE HAS BEEN EXPLANTED AND A NEW DEVICE IMPLANTED AT THE SAME SURGICAL INTERVENTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Presyncope

  MAUDE report 14594425 ↗
• MalfunctionMay 9, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER DECLARED END OF LIFE AND WAS SUBSEQUENTLY SCHEDULED FOR REPLACEMENT. THE DEVICE SHOWED NORMAL BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14341993 ↗
• InjuryApr 26, 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 14214982 ↗

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