INGENIO™ K173Recalls & reported problems

Summary

The FDA's MAUDE database contains 874 adverse event reports that list this exact device (DI 00802526516825), received between Jan 8, 2015 and Sep 4, 2026 — classified as 6 deaths, 525 injuries, 343 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (182 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 874 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602087 ↗
• MalfunctionAug 20, 2026Premature Discharge of Battery

  It was reported that this pacemaker recorded a Code 1003, indicating the voltage was too low for the projected remaining capacity. Device interrogation was ended as the only option. As of this time, this pacemaker remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50335457 ↗
• MalfunctionAug 3, 2026Use of Device Problem; Interrogation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50124093 ↗
• MalfunctionApr 28, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. TECHNICAL SERVICES (TS) SUSPECTED THERE WAS BATTERY DEPLETION. TS RECOMMENDED THE FIELD REPRESENTATIVE SEND IN DEVICE DATA TO PROVIDE A REPLACEMENT WINDOW. IT WAS NOTED THE PATIENT WAS IN BRADYCARDIA. THE PHYSICIAN REFERRED THE PATIENT TO ELECTROPHYSIOLOGY (EP). THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 25017833 ↗
• MalfunctionApr 3, 2026Nonstandard Device

  IT WAS REPORTED THAT THIS PACEMAKER WAS RECEIVED BY POST MARKET QUALITY ASSURANCE FOR ANALYSIS WITHOUT ALLEGATION FROM THE FIELD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779035 ↗
• MalfunctionMar 3, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED DIFFICULTIES TO INTERROGATE. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND PROVIDED GENERAL RECOMMENDATIONS; CONFIRMED THE DEVICE IS SUPPORTED BY THE PROGRAMMER. TS SUSPECTED THE DEVICE BATTERY COULD HAVE DEPLETED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501044 ↗
• InjuryFeb 25, 2026Pacing Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER REACHED END OF LIFE (EOL) STATUS APPROXIMATELY ONE MONTH PRIOR. ADDITIONALLY, THIS PATIENT WAS EXPERIENCING PAUSES. TECHNICAL SERVICES (TS) WAS UNABLE TO DETERMINE THE DURATION OF THE PAUSES; HOWEVER, THE DEFAULT DEVICE BATTERY CAPACITY DEPLETED (BCD) SETTING IS 50 BEATS PER MINUTE (BPM). TS RECOMMENDED THE DEVICE BE REPLACED. THIS PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED. THIS PACEMAKER HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 24445879 ↗
• InjuryFeb 16, 2026Premature Discharge of Battery; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED DUE TO AN UNSPECIFIED PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER WAS RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED DUE TO VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24356863 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24186163 ↗
• MalfunctionJan 8, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED DIFFICULTIES TO INTERROGATE, AS THE PROGRAMMER WAS UNABLE TO LOCATE OR IDENTIFY THE IMPLANTED DEVICE. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED TROUBLESHOOTING GUIDANCE; HOWEVER, THE ISSUE PERSISTED. THE FIELD REPRESENTATIVE WAS PAGED FOR IN-PERSON SUPPORT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT PASSED AWAY ON HOSPICE CARE FROM PNEUMONIA. THE FIELD REPRESENTATIVE NOTED THERE WERE NO ISSUES RELATED TO THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012206 ↗
• MalfunctionDec 29, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXHIBITING UNDERSENSING. THE PATIENT REPORTED FEELING OFF SOMETIMES. TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED REAL VENTRICULAR TACHYCARDIA (VT). THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia; Discomfort

  MAUDE report 23908979 ↗
• MalfunctionDec 9, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759033 ↗
• InjuryNov 18, 2025Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS UNABLE TO BE INTERROGATED BY A CONSULT UNIT, WHICH THIS PACEMAKER IS SUPPORTED BY. THIS PATIENT'S HEART RATE WAS IN THE FIFTIES, AND NO PACING SPIKES WERE OBSERVED ON THE ELECTROGRAM (EGM). ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED WITH A NEW PACEMAKER. A RETURN REQUEST IS BEING SENT TO THE FIELD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 23583547 ↗
• InjuryOct 2, 2025Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED DUE TO UNKNOWN REASONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23205127 ↗
• InjuryOct 2, 2025Signal Artifact/Noise; High impedance; Over-Sensing; High Capture Threshold; Signal Artifact/Noise; High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THIS PACEMAKER AND THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD SAFETY SWITCH (LSS) DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. AFTER THE LSS, THERE WAS OVERSENSING OF NOISY SIGNALS IN THE RV CHANNEL. THE DEVICE WAS REPROGRAMMED TO UNIPOLAR PACING AND BIPOLAR SENSING. IT WAS NOTED THERE WAS A HIGH CAPTURE THRESHOLD. ALSO, THE DEVICE DECLARED EXPLANT. THE DEVICE HAS BEEN IMPLANTED FOR 11 YEARS AND EXPECTATIONS FOR LONGEVITY HAVE BEEN MET. TECHNICAL SERVICES (TS) DISCUSSED REPLACING THE RV LEAD AND THIS PACEMAKER. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THIS PACEMAKER WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23200310 ↗
• InjurySep 26, 2025Failure to Read Input Signal; Failure to Read Input Signal

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER STATED THAT THEIR REMOTE COMMUNICATOR DISPLAYED A RED CALL DOCTOR ICON. THE PATIENT SUBSEQUENTLY PRESENTED TO THEIR CLINIC, WHERE THE DEVICE WAS EXPLANTED AND REPLACED TWO DAYS LATER. AT THIS TIME, THE REASON FOR THE ALERT IS UNKNOWN, AS NO DATA HAD BEEN RECEIVED FROM THE COMMUNICATOR FOR APPROXIMATELY ONE YEAR DUE TO CONNECTION ISSUES. IT WAS ALSO OBSERVED THAT A YELLOW ALERT HAD BEEN STORED BEFORE FOR ATRIAL INTRINSIC AMPLITUDE OUT OF RANGE. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD. THE REASON FOR THE ALERT OBSERVED WAS RELATED TO THE TIME STATED TO BE ONE YEAR APPROXIMATELY WERE THERE WAS NO COMMUNICATION BETWEEN THE DEVICE AND THE COMMUNICATOR. SUBSEQUENTLY, THIS DEVICE WAS THEN EXPLANTED FOR NORMAL BATTERY DEPLETION (NBD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23154605 ↗
• InjurySep 16, 2025Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER REVERTED TO SAFETY MODE, AND THE PATIENT EXPERIENCED SYNCOPE AND A TEN SECOND ASYSTOLE DUE TO PACING INHIBITION. TECHNICAL SERVICES (TS) DISCUSSED UNIPOLAR PACING AND SENSING. A DEVICE REPLACEMENT WAS RECOMMENDED. THIS PACEMAKER WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: Asystole; Syncope/Fainting

  MAUDE report 23067463 ↗
• InjurySep 2, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS PATIENT EXPERIENCED A SYNCOPAL EVENT. THE PATIENT HAD PERFORMED A PATIENT-INITIATED INTERROGATION. UPON REVIEW OF THE DEVICE DATA, IT WAS NOTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND ATRIAL UNDERSENSING WAS ALSO OBSERVED. ATRIAL SENSITIVITY SETTINGS MAY BE CONSIDERED FOR PROGRAMMING OPTIMIZATION. SUCCESSFUL RV AUTOMATIC PACE THRESHOLD TEST AND THE MOST RECENT LEAD TESTS ARE WITHIN NORMAL LIMITS. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 22935425 ↗
• InjuryAug 11, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE PACEMAKER WAS SUSPECTED TO DEPLETE PREMATURELY AND EXHIBITED LONGEVITY CALCULATIONS FROM 2 YEARS TO NOW END OF LIFE (EOL) IN A SPAN OF 1 YEAR. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768659 ↗
• InjuryJul 31, 2025Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER WAS SUSPECTED OF PREMATURE BATTERY DEPLETION (PBD) AS THE LONGEVITY DROPPED FROM 2.5 YEARS TO 6 MONTHS REMAINING IN A SPAN OF 1 YEAR. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY VOLTAGE WAS PREVIOUSLY OUTPERFORMING THE EXPECTATIONS BUT HAS NOW MOVED CLOSER TO EXPECTATIONS. THE LONGEVITY CHANGE IS DUE TO THE SWITCH FROM COULOMETER-BASED CALCULATION TO VOLTAGE BASED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683507 ↗
• MalfunctionJul 1, 2025Over-Sensing; Low impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED LOW RIGHT VENTRICULAR (RV) PACE IMPEDANCE MEASUREMENTS OF LESS THAN 200 OHMS AT A GENERATION CHANGE PROCEDURE. TECHNICAL SERVICES (TS) REVIEWED DEVICE DATA AND NOTED THAT THERE WAS MYOPOTENTIAL OVERSENSING ON THE RV CHANNEL INDICATIVE OF INSULATION FAILURE AND RECOMMENDED LEAD REVISION. THE PHYSICIAN CHOSE TO NOT REPLACE THE LEAD AT THIS TIME. THIS PACEMAKER WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375253 ↗
• MalfunctionJun 30, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED AND THERE WERE NO ALLEGATIONS REPORTED. THIS DEVICE WAS RECEIVED BY POST MARKET QUALITY ASSURANCE FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355798 ↗
• MalfunctionJun 27, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS DEVICE WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346633 ↗
• InjuryJun 20, 2025Adverse 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 22299027 ↗
• MalfunctionJun 18, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY IDENTIFIED A PRODUCT PERFORMANCE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285469 ↗