ALTRUA™ 40 S404Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00802526484452), received between Apr 25, 2016 and Sep 9, 2026 — classified as 22 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (9 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 33 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 9, 2022Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER WAS NOTED TO HAVE A HIGH PACING RATE. THE PATIENT HAD PREVIOUSLY BEEN PUT ON A LIFE VEST AFTER A HAVING EXPERIENCED A HEART ATTACK. THE FIELD REPRESENTATIVE PROGRAMMED THE MINUTE VENTILATION (MV) SENSOR OFF. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT ELECTROMAGNETIC INTERFERENCE FROM THE VEST WAS LIKELY AFFECTING THE MV SIGNAL AND BY PROGRAMMING THE MV SENSOR OFF, THE PACING FROM THE DEVICE WAS AFFECTED. TS DISCUSSED HOW EQUIPMENT SUCH AS THE VEST CAN AFFECT MV SIGNAL. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tachycardia

  MAUDE report 14067543 ↗
• MalfunctionMar 5, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE DEVICE WAS SUSPECTED TO BE EXHIBITING PREMATURE BATTERY DEPLETION BEHAVIOR. DURING THE MOST RECENT INTERROGATION, IT WAS OBSERVED THAT THE DEVICE HAD REACHED END OF LIFE (EOL). THE PREVIOUS DEVICE INTERROGATION SHOWED THAT THE REMAINING BATTERY LONGEVITY HAD 2.5 YEARS REMAINING. REPROGRAMMING CHANGES WERE MADE, AND THE OUTPUTS WERE INCREASED. A COPY OF DEVICE MEMORY WAS SAVED AND SUBMITTED TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR ANALYSIS. ENGINEERING REVIEW, CONFIRMED NORMAL DEVICE OPERATION, AND DISCUSSED THAT THE INCREASE IN OUTPUT SETTINGS HAS THE POTENTIAL TO PULL ELECTIVE REPLACEMENT INDICATOR (ERI) FORWARD. THIS DEVICE HAD BEEN IMPLANTED FOR NEARLY 9.5 YEARS. THIS DEVICE WAS EXPLANTED FOR NORMAL ERI. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13677544 ↗
• MalfunctionJan 11, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGE PROCEDURE, THIS PACEMAKER WAS PACING FASTER THAN EXPECTED INCREASING THE PATIENT'S RATE TO 130 BPM. THE PHYSICIAN SUSPECTED AN OVER-REACTION/RESPONSE TO THE R-R INTERVAL. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13228023 ↗
• MalfunctionNov 3, 2021Signal Artifact/Noise; Low impedance; High Capture Threshold; Signal Artifact/Noise; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER WAS SEEN IN-CLINIC FOR A ROUTINE FOLLOW UP. UPON DEVICE INSPECTION, SEVERAL V-TACHY EPISODES WERE RECORDED. ADDITIONAL TESTING WAS PERFORMED TO REPRODUCE NOISE WITH AGGRESSIVE ISOMETRICS, PALPATING THE DEVICE ETC. BUT NO NOISE WAS NOTED. DATA ANALYSIS WAS PROVIDED TO BOSTON SCIENTIFIC TECHNICAL SERVICES FOR REVIEW AND NOISE WAS CONFIRMED. BOSTON SCIENTIFIC TECHNICAL SERVICES RECOMMENDED TO CONTINUE MONITORING THIS PATIENT VIA LATITUDE HOME MONITORING SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS PROVIDED ON 07SEP2021, IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER WAS SEEN IN-CLINIC FOR RIGHT VENTRICULAR (RV) MONITORING. THE RV PACING IMPEDANCE SHOWED A DECREASE TO 120 OHMS AND AN RV THRESHOLD INCREASED. THERE WAS NO ASYSTOLE AND NO SYMPTOMS CONSISTENT WITH LOSS OF CAPTURE DOCUMENTED BY THE PATIENT. THE DEVICE WAS REPROGRAMMED. THE PATIENT WILL BE SCHEDULED FOR A NEW RV LEAD IN THE COMING MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER AND COMPETITOR RV LEAD REMAINS IN-SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749669 ↗
• InjuryOct 13, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER GAS GAUGE INDICATED HALF A YEAR SINCE THREE MONTHS AGO AND MAGNET RATE WAS AT NINETY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) THEN EXPLAINED THAT MAGNET RATE ARE MUCH BETTER INDICATOR. TO DATE, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED. ADDITIONAL INFORMATION RECEIVED WHICH INDICATED THAT THE DEVICE WAS SURGICALLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12628412 ↗
• InjuryAug 3, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER DEVICE HAD TWO YEARS REMAINING BATTERY LONGEVITY BUT HIT END OF LIFE (EOL) A FEW MONTHS LATER. MOREOVER, THIS DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE WAS THEN RETURNED TO LABORATORY AND WAS ANALYZED. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271792 ↗
• InjuryNov 26, 2020Signal Artifact/Noise; Over-Sensing; Pacing Problem; Data Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Data Problem

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT AN EXPLANT PROCEDURE FOR THIS DUAL CHAMBER PACEMAKER. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS REPORT IS BEING FILED AS DEVICE EVALUATION WAS COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10908418 ↗
• InjuryJul 22, 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 10311185 ↗
• MalfunctionJul 6, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED DURING ONGOING USE, PREMATURE BATTERY DEPLETION WAS OBSERVED. THE PATIENTS DEVICE HAS BEEN DEPLETING AT APPROXIMATELY 2X THE STATED RATE. THE LONGEVITY REDUCED BY TWO YEARS IN ONE YEAR'S TIME. THE PATIENT WAS SEEN IN CLINIC LAST YEAR AND WAS QUOTED 2.5 YEARS BATTERY REMAINING, AND IS NOW QUOTED AT LESS THAN 6 MONTHS REMAINING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10236568 ↗
• MalfunctionApr 15, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER PREVIOUSLY SHOWED SIX MONTHS REMAINING LONGEVITY. DURING THE RECENT DEVICE CHECK, THE DEVICE WAS AT ONE YEAR REMAINING LONGEVITY. AS OF THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9965602 ↗
• InjuryApr 9, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE DEVICE WAS SUSPECTED TO BE DEPLETING PREMATURELY. THIS DEVICE HAS BEEN SCHEDULED FOR REPLACEMENT AND RETURN TO BOSTON SCIENTIFIC FOR ANALYSIS POST EXPLANT, IS EXPECTED. NO RESULTING ADVERSE PATIENT EFFECTS WERE REPORTED AT THIS TIME. SUBSEQUENTLY, THE UNIT WAS EXPLANTED AND RETURNED FOR ANALYSIS.

  Patient problems: No Code Available

  MAUDE report 9947374 ↗
• InjuryJan 6, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PACEMAKER HAD HIGH OUTPUTS AND DECLARED ELECTIVE REPLACEMENT TIME (ELECTIVE REPLACEMENT TIME (ERT). THERE WAS ALSO DIFFICULTY GETTING IMPEDANCE. THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9550727 ↗
• InjuryJan 6, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER'S BATTERY DROPPED FROM TWO YEARS TO LESS THAN SIX MONTHS IN A SPAN OF SEVEN MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED YO HAVE THE PATIENT CHECKED AND TO PERFORM AN ENGINEERING ANALYSIS OF THE DEVICE'S BATTERY STATUS. AS OF THIS MOMENT, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 9549857 ↗
• InjuryJan 6, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY CAPPED AND REPLACED DUE TO HIGH THRESHOLDS AND OVERSENSING. AND DURING THE PRE-OPERATIVE CHECK, IT WAS DETERMINED THAT THE PACEMAKER BATTERY HAD GONE FROM ONE YEAR TO END OF LIFE (EOL) IN SIX MONTHS. SUBSEQUENTLY, THE DEVICE WAS ALSO EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 9549852 ↗