ALTRUA 20Recalls & reported problems across all models

We found 5 models of ALTRUA 20 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 64 adverse event reports in the FDA's MAUDE database, received between Jul 12, 2016 and Dec 4, 2025 — classified as 42 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (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 20 problems

ALTRUA 20 models

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

• ALTRUA™ 20 S208

  Implantable pulse generator, pacemaker (non-CRT)
  32 reports
• ALTRUA™ 20 S203

  Implantable pulse generator, pacemaker (non-CRT)
  14 reports
• ALTRUA™ 20 S201

  Implantable pulse generator, pacemaker (non-CRT)
  7 reports
• ALTRUA™ 20 S205

  Implantable pulse generator, pacemaker (non-CRT)
  6 reports
• ALTRUA™ 20 S204

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

Recent ALTRUA 20 adverse event reports

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

• MalfunctionDec 4, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem; High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS UNABLE TO BE INTERROGATED AS IT WAS GETTING AN ERROR MESSAGE ON TWO COMMUNICATORS. THE DEVICE EXPERIENCED SAFETY SWITCH. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED, THE PHYSICIAN PLANS TO PERFORM AN EXPLANT ONCE THE DEVICE REACHES ELECTIVE REPLACEMENT INDICATOR (ERI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23712448 ↗
• MalfunctionAug 20, 2025Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS UNABLE TO BE READ BY INTERROGATOR. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851790 ↗
• MalfunctionFeb 13, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM EXHIBITED INTERMITTENT LOSS OF CAPTURE (LOC) ON THE RIGHT VENTRICULAR (RV) LEAD. THE INVOLVED LEAD IS A NON-BOSTON SCIENTIFIC AND HAS BEEN IMPLANTED SINCE 1990. TECHNICAL SERVICES (TS) RECOMMENDED FURTHER EVALUATION OF THIS PATIENT AND LEAD. REPROGRAMMING WAS PERFORMED AND THRESHOLDS WERE INCREASED TO 3 V. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379683 ↗
• MalfunctionOct 13, 2024Telemetry Discrepancy; Telemetry Discrepancy

  IT WAS REPORTED THAT THIS PACEMAKER COULD NOT BE INTERROGATED BY DIFFERENT PROGRAMMERS. DIFFERENT TROUBLESHOOTING OPTIONS WERE DISCUSSED WITH THE DIFFERENT PROGRAMMERS AND STILL THE DEVICE COULD NOT BE INTERROGATED. AN X RAY WAS COMPLETED TO CONFIRM THE DEVICE WAS STILL IMPLANTED. IT WAS RECOMMENDED TO CONSIDER THE PATIENT UNPROTECTED AND REPLACE DEVICE. THE PACEMAKER REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436512 ↗
• MalfunctionSep 12, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WENT FROM ONE YEAR OF LONGEVITY REMAINING TO END-OF-LIFE (EOL) STATUS IN A SPAN OF SIX MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE HIGH LEVEL OF HOW THIS DEVICE MANAGES LONGEVITY AS IT RELATES TO CURRENT BINS. THIS DEVICE WAS LIKELY OPERATING ON THE EDGE OF A CURRENT, THEN A SMALL CHANGE IN POWER CONSUMPTION CAUSED IT TO HOP TO A HIGHER CURRENT BIN, RESULTING IN ELECTIVE REPLACEMENT INDICATOR (ERI). TS STATED THAT THIS IS NOT LIKELY A BATTERY MALFUNCTION BUT AN OUTLIER OBSERVATION DUE TO THE BATTERY MANAGEMENT DESIGN. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17730667 ↗
• MalfunctionJul 11, 2023Signal Artifact/Noise; Over-Sensing; High Capture Threshold; Signal Artifact/Noise; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED NOISE AND OVERSENSING ON THE VENTRICULAR CHANNEL. HIGH CAPTURE THRESHOLDS WERE NOTED AS WELL. THE INVOLVED RIGHT VENTRICULAR (RV) LEAD IS A NON BOSTON SCIENTIFIC PRODUCT. THE PATIENT REPORTED EXPERIENCING POCKET STIMULATION. A FOLLOW UP WITH CARDIOLOGY WAS SCHEDULED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 17302155 ↗
• MalfunctionJul 7, 2023Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THE FIELD REPRESENTATIVE WAS NOT ABLE TO INTERROGATE THIS PATIENT WITH A PACEMAKER. PACING WAS CONFIRMED AT 100BPM WITH MAGNET APPLICATION USING BOTH THE ELECTROCARDIOGRAM AND EXTERNAL DEFIBRILLATOR. THE PATIENT WAS MOVED TO DIFFERENT LOCATIONS AND MULTIPLE PROGRAMMERS WERE USED AND IT WAS STILL UNSUCCESSFUL. THE ATTENDING PHYSICIAN WAS NOTIFIED AND WILL CONSULT WITH THE ELECTROPHYSIOLOGIST. AT THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278401 ↗
• MalfunctionMay 30, 2023Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER COULD NOT BE READ AND INTERROGATED. THERE WAS A POSSIBILITY THAT ELECTIVE REPLACEMENT INDICATOR HAD BEEN REACHED. DISCUSSED MAGNET RESPONSE TO CHECK BATTERY STATUS. THE FIELD REPRESENTATIVE WAS NOT MADE AWARE OF THE SITUATION. HE SUGGESTED THE PACEMAKER MIGHT HAVE BEEN CHANGED TO A NON-BSC DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017814 ↗
• MalfunctionJul 26, 2022Failure to Capture; High impedance; Over-Sensing; Under-Sensing; Failure to Capture; High impedance; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE DEVICE EXHIBITED HIGH OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS. SIX MONTHS AGO, THIS DEVICE REACHED AN ELECTIVE REPLACEMENT INDICATOR (ERI). THE PATIENT IS NOT DEPENDENT. ADDITIONALLY, INTERMITTENTLY SIGNALS OVERSENSED AND UNDERSENSED WERE OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. AN INTERROGATION WAS TRIED PERFORMED. HOWEVER; THIS DEVICE WAS UNABLE TO BE INTERROGATED. TROUBLESHOOTING EFFORTS WERE PERFORMED. IT WAS DETERMINED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE MEASUREMENTS AND THE RA LEAD EXHIBITED HIGH OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS. LOSS OF CAPTURE WAS ALSO SEEN ON THE RA CHANNEL. LEADS REPLACEMENT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108755 ↗
• InjuryJul 19, 2022Signal Artifact/Noise; Over-Sensing; Connection Problem; Impedance Problem; Material Integrity Problem; High Capture Threshold; Signal Artifact/Noise; Over-Sensing; Connection Problem; Impedance Problem; Material Integrity Problem; High Capture Threshold

  IT WAS REPORTED THAT THIS IMPLANTABLE PULSE GENERATOR (PACEMAKER) WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION, BUT ALSO DUE TO SUSPICIONS OF INTERACTION ISSUES WITH THE LEFT ATRIUM (LA) LEAD. REPORTEDLY, IMPEDANCE ISSUES, HIGH CAPTURE THRESHOLDS AND NOISE EVENTS WERE NOTICED FOR MONTHS, AND IT WAS BELIEVED THERE WAS AN INTEGRITY ISSUE WITH THE LA LEAD. HOWEVER, DURING THE REPLACEMENT PROCEDURE, THE LEAD WAS TESTED IN THE ANALYZER AND NO INADEQUATE MEASUREMENTS WERE NOTICED. THUS, IT WAS DECIDED TO KEEP THE LEAD IMPLANTED AND ONLY THE PACEMAKER WAS REPLACED. IN ADDITION, IT WAS STATED THAT THE PATIENT FELL A FEW TIMES OVER THE LAST MONTHS, NOT RELATED TO THIS PACEMAKER PERFORMANCE, AND IT WAS SUSPECTED THAT THIS CAUSED THE CONNECTION ISSUE. THIS PACEMAKER IS EXPECTED TO BE RETURNED FOR ANALYSIS AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059875 ↗
• InjuryJul 13, 2022Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER SHOWED AN EVENT WERE NOISY SIGNALS WERE OVERSENSED. THERE WAS NO MALFUNCTION RELATED TO THE SYSTEM LEADS. THESE LEADS WERE UNIPOLAR. A NEW SYSTEM WAS IMPLANTED ON THE OPPOSITE SIDE WITHOUT ANY PROBLEMS. THE EXISTING SYSTEM WAS NOT REMOVED AND REMAINS IMPLANTED. THE SENSE AND PACE RATE WAS REPROGRAMMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14999184 ↗
• InjuryJul 4, 2022Device Sensing Problem; Data Problem; Device Sensing Problem; Data Problem

  IT WAS REPORTED THAT THIS PATIENT WAS PRESENTED FOR AN OFFICE CHECK. UPON INTERROGATION, THE HEALTH CARE PROFESSIONAL REACHED OUT TO TECHNICAL SERVICES (TS) TO REVIEW THE PRESENTING ELECTROGRAMS (EGM). UPON REVIEW, IT WAS NOTED THAT THE PATIENT HAS FREQUENT PREMATURE VENTRICULAR CONTRACTION (PVC)S. IT WAS ALSO REPORTED THAT THE PATIENT HAS PREVIOUSLY UNDERGONE AN ABLATION PROCEDURE DUE TO AN UNDERLYING PATIENT CONDITION. DEVICE TESTING WAS PERFORMED AND ALL MEASUREMENTS WERE REPORTED TO BE WITHIN NORMAL RANGE. SUBSEQUENTLY, THE PATIENT UNDERWENT A RIGHT VENTRICULAR (RV) LEAD REVISION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN REQUESTED THE DEVICE TO BE REPROGRAMMED PRIOR TO THE NEW RV LEAD BEING INSERTED. POST DEVICE REPROGRAMMING, IT WAS NOTED THAT THE DEVICE WAS NO LONGER PACING IN THE RV AND THE PACE AND SENSE CONFIGURATION HAD CHANGED, THEREFORE ADDITIONAL REPROGRAMMING WAS PERFORMED. TS WAS CONSULTED AND COULD NOT CONFIRM THE REASON FOR THIS RV LEAD CONFIGURATION CHANGE, BUT RECOMMENDED THE DEVICE BE SENT IN FOR FURTHER ANALYSIS. ULTIMATELY, THE PHYSICIAN OPTED TO EXPLANT AND REPLACE THE PACEMAKER. THE RV LEAD WAS SUCCESSFULLY SURGICALLY ABANDONED AND REPLACED. NO ADDITION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911436 ↗
• MalfunctionJun 6, 2022Signal Artifact/Noise; High impedance; Failure to Read Input Signal; Signal Artifact/Noise; High impedance; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS SYSTEM HAD PREVIOUSLY EXHIBITED ATRIAL NOISE IN BIPOLAR CONFIGURATION. OUT OF RANGE PACING IMPEDANCE MEASUREMENTS HAD TRIGGERED THE LEAD SAFETY SWITCH (LSS). THE CALLER INQUIRED ABOUT THE SPECIFIC MEASUREMENT THAT TRIGGERED THE LSS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT INFORMED THE CALLER THAT IF THE ACTUAL VALUE IS NOT AVAILABLE, THE LSS IS TRIGGERED WHEN THERE WAS AN IMPEDANCE GREATER THAN 2500 OHMS. THERE WAS A SMALL DECREASE OF 100 OHMS IDENTIFIED FROM TWO MONTHS PRIOR. THE CONSULTANT DISCUSSED OPTIONS FOR THIS PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14606125 ↗
• InjuryMay 27, 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: Pocket Erosion; Unspecified Infection

  MAUDE report 14528833 ↗
• InjuryMay 27, 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. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 14528351 ↗

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