ALTRUA™ 20 S208Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00802526484421), received between Jul 12, 2016 and Dec 4, 2025 — classified as 24 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Defective Device” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, 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 ↗
• 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 ↗
• 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 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 ↗
• MalfunctionApr 22, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS DEVICE WAS AT END OF LIFE (EOL) STATE. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS SURGICALLY EXPLANTED DUE TO NORMAL BATTERY DEPLETION (NBD). NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS. DEVICE ANALYSIS CONFIRMED THE REPORTED CLINICAL OBSERVATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190380 ↗
• InjuryAug 4, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAD AN UNEXPECTED DROP IN BATTERY FROM ONE YEAR TO ELECTIVE REPLACEMENT TIME (ERT). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED LIKELY AN ERRONEOUS BATTERY MEASUREMENTS AND COULD BE A MISMATCH BETWEEN PROGRAMMER AND DEVICE. IN ADDITION, IT WAS NOTED THAT THE OUTPUT HAD INCREASED FROM THE PREVIOUS CHECK FROM THREE POINT FIVE TO FOUR VOLTS. TS THEN DISCUSSED THIS COULD LIKELY CAUSED THE DEVICE TO DECLARE ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED. THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278174 ↗
• InjuryJul 3, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAD A MAGNET RATE OF 90 FROM THREE MONTHS AGO WITH LESS THAN 0.5 MONTHS BATTERY REMAINING BUT NOT ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE HAD REACHED END OF LIFE (EOL) IN LESS THAN A MONTH AGO. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12113240 ↗
• InjuryJul 3, 2021Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE PACEMAKER DEVICE AND RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE, WHICH WAS OVERSENSED RESULTING IN INAPPROPRIATE MODE SWITCH EPISODES. ALSO, THERE WERE HIGH OUT OF RANGE RA LEAD PACE IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS. THE CAUSE OF THE NOISE AND HIGH IMPEDANCE MEASUREMENTS IS UNKNOWN. THE BOSTON SCIENTIFIC REPRESENTATIVE INDICATED THEY ARE NOT AWARE OF ANY RELATED PATIENT SYMPTOMS. THE PACEMAKER DEVICE WAS EXPLANTED, THE RA LEAD WAS SURGICALLY ABANDONED AND BOTH PRODUCTS WERE REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112953 ↗
• InjuryJan 15, 2021Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER HAD LESS THAN SIX MONTHS REMAINING WITH MAGNET RATE OF NINETY BEATS PER MINUTE. ATRIAL LEAD WAS THEN TURNED OFF FOR CHRONIC ATRIAL FIBRILLATION (AF). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IT SOUNDED LIKE IT SHOULD GO BACK TO A HUNDRED BEATS PER MINUTE. THIS DEVICE REMAINED AT NINETY BEATS PER MINUTE POST PROGRAMMING. IT WAS THEN RECOMMENDED TO RECHECK THE DEVICE TO SEE THE RESULTING LONGEVITY PROJECTION AND MAGNET RATE. MOREOVER, THE ASSOCIATED INVESTIGATION DETERMINED THAT THE BATTERY STATUS INDICATORS WERE DIFFERENT THAN EXPECTED. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11181983 ↗
• InjuryOct 29, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS PACEMAKER PREVIOUSLY DISPLAYED TWO YEARS REMAINING WITH INCREASED RIGHT VENTRICULAR (RV) OUTPUTS THEN REACHED ELECTIVE REPLACEMENT TIME (ERT) AFTER A MONTH. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED THAT LONGEVITY CALCULATION IS NOT POSSIBLE WITH OLD DEVICE AND RECOMMENDED DEVICE REPLACEMENT FOR EVALUATION. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 10756488 ↗
• InjuryOct 2, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER PREVIOUSLY SHOWED TWO YEARS REMAINING LONGEVITY. DURING THE RECENT DEVICE CHECK, THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) VERIFIED THAT THERE WERE NO PROGRAMMING CHANGES AND RECOMMENDED TO REPLACE THE DEVICE AND RETURN FOR ANALYSIS. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 10620694 ↗
• InjuryJul 27, 2020Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED DUE TO UNKNOWN REASONS. THE ENTIRE SYSTEM WAS REMOVED FROM SERVICE. THIS DEVICE APPARENTLY EXHIBITED A MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Code Available

  MAUDE report 10329556 ↗
• InjuryApr 17, 2020Signal Artifact/Noise; Over-Sensing; High Capture Threshold; Signal Artifact/Noise; Over-Sensing; High Capture Threshold

  THIS SUPPLEMENTAL REPORT IS BEING FILED DUE TO THE COMPLETED EVALUATION OF THIS PRODUCT.

  Patient problems: No Code Available

  MAUDE report 9974401 ↗
• InjuryJan 28, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT BATTERY LIFE OF THIS PACEMAKER WENT FROM TWO YEARS REMAINING TO HALF A YEAR REMAINING IN A SPAN OF ONE MONTH. ADDITIONALLY, THE DEVICE OUTPUT HAD BEEN INCREASED WHICH CONTRIBUTED TO DROP IN DEVICE LONGEVITY. THE PACEMAKER WAS NOT AT ELECTIVE REPLACEMENT INDICATOR (ERI) YET AND STILL REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9638004 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT DEVELOPED AN INFECTION. AS RESULT, A SYSTEM REVISION WAS PLANNED. REASONABLE EVIDENCE SUGGESTS THIS DEVICE WAS EXTRACTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 9611919 ↗
• InjuryNov 5, 2019Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS DEPLETING PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 9279356 ↗
• InjuryOct 23, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER HAD PREMATURELY DEPLETED. SURGICAL INTERVENTION WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9225684 ↗
• MalfunctionAug 7, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PACEMAKER DEVICE WENT FROM FIVE YEARS REMAINING LONGEVITY TO TWO AND A HALF YEARS REMAINING LONGEVITY SEVERAL MONTHS AGO. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED REPROGRAMMING OPTIONS. THE BATTERY STATUS CHANGED TO FIVE YEARS REMAINING LONGEVITY AFTER PROGRAMMING MADE. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8872369 ↗
• InjuryAug 5, 2019Defective Device; Interrogation Problem; Defective Device; Interrogation Problem

  IT WAS REPORTED THAT THIS PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER WHAT APPEARED TO BE A SYNCOPAL EPISODE. THE PATIENT FELL DURING THE EPISODE. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND AN EXTERNAL DEFIBRILLATOR WAS APPLIED TO THE PATIENT. HOWEVER, THE EXTERNAL DEFIBRILLATOR DID NOT DETECT A TREATABLE RHYTHM AND NO SHOCK WAS DELIVERED. THE HEALTH CARE PROVIDER EXPERIENCED SOME DIFFICULTY INTERROGATING THE PATIENT'S DEVICE, BUT A BOSTON SCIENTIFIC REPRESENTATIVE WAS ABLE TO COMPLETE THE INTERROGATION. THE DEVICE HAD NOT STORED ANY EPISODES ON THE DAY OF THE SYNCOPE. SUBSEQUENTLY, THE PATIENT'S DEVICE WAS EXPLANTED. IT WAS NOTED THAT THE DEVICE HAD BEEN ACTIVE FOR GREATER THAN 9 YEARS AND MAY HAVE BEEN REACHING THE END OF ITS BATTERY LIFE. IT WAS NOTED THAT THE PATIENT EXPERIENCED SOME CHEST PAIN ASSOCIATED WITH THE CPR, BUT NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Chest Pain; Fall; No Code Available; Syncope

  MAUDE report 8860703 ↗
• InjuryJun 21, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PATIENT PRESENTED FOR EVALUATION DUE TO PALPITATIONS AND SYNCOPE. NO EPISODES WERE STORED ON THE DEVICE DURING THE PERIOD OF THE REPORTED SYNCOPE. BOSTON SCIENTIFIC TECHNICAL SERVICES SUGGESTED THAT THE PATIENT FOLLOW UP WITH THEIR CARDIOLOGIST. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED

  Patient problems: Palpitations; Syncope

  MAUDE report 8722461 ↗
• InjuryApr 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 8512138 ↗
• InjuryApr 11, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE BATTERY HAD ALLEGEDLY PREMATURELY DEPLETED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8505183 ↗
• MalfunctionFeb 5, 2019Low impedance; High Capture Threshold; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THE CLINIC NOTED A LEAD SAFETY SWITCH (LSS) HAD OCCURRED FOR A LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENT TWO YEARS EARLIER. IT WAS FURTHER NOTED THAT THE THRESHOLD MEASUREMENT HAD INCREASED. THE CLINIC NOTED THEY WERE CONTINUING TO MONITOR THE PATIENT. THE PACEMAKER AND ANOTHER MANUFACTURER'S RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS REMAIN IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8306124 ↗