ALTRUA™ 40 S401Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00802526484438), received between Jul 16, 2016 and Jan 21, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Capture” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJul 6, 2020Premature Discharge of Battery; Interrogation Problem; Premature Discharge of Battery; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAD VARYING LONGEVITY ESTIMATES. IN (B)(6) 2014 THERE WAS 4.5 YEARS REMAINING. IN (B)(6) 2016 IT WAS 3 YEARS BUT IN (B)(6) 2020 THERE IS MORE THAN 5 YEARS AND BATTERY STATUS IS BEGINNING OF LIFE (BOL). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) NOTED THAT DUE TO LACK OF THERAPY NEEDS THIS IS NOT UNEXPECTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE HAS BEEN DIFFICULTY INTERROGATING THIS DEVICE. IN THE PAST THE DEVICE COULD NOT BE INTERROGATED WHILE THE PATIENT WAS LAYING DOWN BUT COULD WHILE THEY WERE SEATED. MORE RECENTLY THE DEVICE COULD NOT BE INTERROGATED DESPITE TRYING TWO DIFFERENT PROGRAMMERS, TWO DIFFERENT POWER CABLES AND THREE DIFFERENT WANDS. AFTER AN HOUR OF TRYING TO INTERROGATE THE PHYSICIAN STOPPED TRYING. THE DEVICE IS NOT NEEDED BY THE PATIENT AS THEY HAVE BEEN IN PERMANENT ATRIAL FIBRILLATION (AF) FOR YEARS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10237466 ↗
• InjuryNov 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER HAD INFECTION AND EROSION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS PACEMAKER REMAINS IN SERVICE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 9285879 ↗
• InjuryApr 26, 2019Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  THIS SUPPLEMENTAL REPORT IS BEING FILED AS THE DEVICE EVALUATION WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8557692 ↗
• InjuryDec 4, 2018Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  THIS SUPPLEMENTAL REPORT IS BEING FILED TO PROVIDE THE UPDATED CONCLUSION CODE BASED ON TREND ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8129668 ↗
• InjuryOct 18, 2018High impedance; Over-Sensing; Ambient Noise Problem; High impedance; Over-Sensing; Ambient Noise Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CONFIGURATION ON THE RIGHT ATRIAL (RA) LEAD SWITCHED TO UNIPOLAR AS A RESULT OF HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. WHILE IN UNIPOLAR CONFIGURATION, THERE WERE A LOT OF EPISODES OF OVERSENSING. THE CONFIGURATION WAS REPROGRAMMED TO BIPOLAR AND MINUTE VENTILATION (MV) WAS PROGRAMMED ON. AFTER THAT, MV CHOP WAS OBSERVED. AS A RESULT, MV WAS PROGRAMMED OFF AND THE NOISE WAS RESOLVED. NO FURTHER CHANGES WERE MADE TO THE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7981215 ↗
• InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 6929742 ↗
• InjuryJul 16, 2016Failure to Capture; Use of Device Problem; Capturing Problem; Adverse Event Without Identified Device or Use Problem; Failure to Capture; Use of Device Problem; Capturing Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE PRODUCT WAS EXPLANTED WHEN THE NEW SYSTEM WAS IMPLANTED.

  Patient problems: Cardiac Enzyme Elevation; Sepsis; Unspecified Infection

  MAUDE report 5800340 ↗