INGENIO™ K172Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00802526516818), received between Apr 21, 2016 and Jan 23, 2026 — classified as 28 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (17 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED NOISE WHICH WAS OVERSENSED IN THE RIGHT VENTRICULAR (RV) CHANNEL. TECHNICAL SERVICES (TS) WAS CONTACTED AND REVIEWED THE DATA. THIS PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167450 ↗
• InjuryNov 19, 2025Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS PACEMAKER WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. DURING THE PROCEDURE, WHEN THE PULSE GENERATOR WAS REMOVED FROM THE IMPLANT POCKET, THE SYSTEM WITH A RIGHT VENTRICULAR (RV) LEAD DEMONSTRATED PACING INHIBITION, LOSS OF CAPTURE, NOISE, OVERSENSING AND MV OVERSENSING. AS A TROUBLESHOOTING STEP, THE RV LEAD WAS SWITCHED TO A PACING SYSTEM ANALYZER. THE PATIENT IS PACEMAKER-DEPENDENT AND EXPERIENCED A BRIEF EPISODE OF ASYSTOLE AND A CARDIAC ARREST. TECHNICAL SERVICES CONFIRMED THAT, FOR THIS PATIENT, MV OVERSENSING CAN BE ASSOCIATED TYPICALLY WITH HIGH IMPEDANCE SCENARIOS, AND IN THIS CASE, NOISE WAS OBSERVED WHILE THE PULSE GENERATOR WAS OUTSIDE THE IMPLANT POCKET, SUGGESTING A POSSIBLE LEAD-TO-HEADER CONTACT ISSUE DURING MANIPULATION. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED, AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. THE RV LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION INDICATED THAT A LEAD LEAKAGE FAULT WAS RECORDED. THIS FAULT INDICATES THAT THE PULSE GENERATOR (PG) DETECTED EXTERNAL ENERGY ON THE DEVICE, WHEN LEAD LEAKAGE IS DETECTED, THE SYSTEM TRIGGERS AN INTERRUPT THAT OP

  Patient problems: Asystole; Cardiac Arrest

  MAUDE report 23597134 ↗
• MalfunctionMay 12, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER EXHIBITED LONGEVITY CALCULATIONS FROM 2 YEARS TO 3 MONTHS REMAINING IN A SPAN OF 8 MONTHS. DATA WAS SENT FOR ENGINEERING ANALYSIS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004769 ↗
• MalfunctionJun 20, 2024Signal Artifact/Noise; Failure to Capture; Signal Artifact/Noise; Failure to Capture

  IT WAS REPORTED THAT THERE WAS POSSIBLE LOSS OF CAPTURE (LOC) ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL OF THIS PACEMAKER SYSTEM. TECHNICAL SERVICES (TS) REVIEWED THE PRESENTING ELECTROGRAM (EGM) AND FOUND TWO SMALL DEFLECTIONS PRESENT WITH NO OVERSENSING. THESE WERE ATTRIBUTED TO POSSIBLE ECTOPIC BEATS. TS SUGGESTED FURTHER EVALUATION IN CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS PACEMAKER SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575022 ↗
• MalfunctionMay 23, 2024Signal Artifact/Noise; Over-Sensing; Off-Label Use; Signal Artifact/Noise; Over-Sensing; Off-Label Use

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED NOISE OVER SENSING DURING A NON-CONDITIONAL MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE. VENTRICULAR PACING MARCHED THROUGH THE OBSERVED NOISE AT THE MRI PROCEDURE. THE PACEMAKER REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19388751 ↗
• MalfunctionMay 20, 2024Defective 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 DETERMINED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION IDENTIFIED BY A PRODUCT PERFORMANCE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353983 ↗
• MalfunctionMar 27, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE PACEMAKER EXHIBITED LONGEVITY CALCULATIONS FROM 4.5 YEARS TO 1.5 YEARS REMAINING IN A SPAN OF 1 MONTH. DATA WAS SENT FOR ENGINEERING ANALYSIS. ANALYSIS SHOWED THAT THE BATTERY VOLTAGE IS SIGNIFICANTLY HIGHER THAN EXPECTED GIVEN THE DURATION OF IMPLANT AND AMOUNT OF CELL DEPLETION. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18989346 ↗
• MalfunctionFeb 15, 2024Signal Artifact/Noise; Failure to Capture; Signal Artifact/Noise; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT WITH THIS PACEMAKER DEVICE EXHIBITED NOISY SIGNALS ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE HEALTH CARE PROFESSIONAL (HCP) HAD CALLED IN AND WAS QUESTIONING IF THERE WAS LOSS OF CAPTURE (LOC) AS THERE WERE COUPLE OF FUSION MARKERS. THE PRESENTING ELECTROGRAM (EGM) SHOWED NOISE, HOWEVER IT WAS NOT SENSED. TECHNICAL SERVICES (TS) STATED THAT THERE WAS T-WAVE POST EACH OF THE PACED INDICATING THERE WAS DEPOLARIZATION. THE THRESHOLD VALUES WERE STABLE. IMPEDANCES WERE FLUCTUATING HOWEVER THEY WERE WITHIN THE NORMAL RANGE. THE PLAN WAS TO CONTINUE MONITORING. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711846 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS PART OF SYSTEM REVISION DUE TO POCKET EROSION. THE PATIENT REPORTEDLY EXPERIENCED SIGNIFICANT WEIGHT LOSS AND SUSPENDERS ERODED POCKET. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 18646562 ↗
• MalfunctionApr 6, 2022Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PACEMAKER WAS UNABLE TO BE INTERROGATED BY 2 PROGRAMMERS. A MAGNET WAS APPLIED IN WHICH THERE WERE NO PACING SPIKES OBSERVED. THE PATIENT WAS NOT PACEMAKER DEPENDENT AT THE TIME. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE FIELD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON BOSTON SCIENTIFIC DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14032650 ↗
• InjuryOct 13, 2021Adverse 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 AND EROSION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 12627850 ↗
• MalfunctionApr 21, 2021High impedance; High impedance

  IT WAS REPORTED THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS. TECHNICAL SERVICES (TS) RECOMMENDED BRINGING THE PATIENT IN CLINIC FOR DEVICE INTERROGATION AND RV LEAD EVALUATION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS SEEN IN CLINIC FOR DEVICE INTERROGATION AND LEAD EVALUATION, AND ALL MEASUREMENTS WERE SATISFACTORY. THE PATIENT WOULD CONTINUE TO BE MONITORED REMOTELY. THIS PACEMAKER AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704681 ↗
• MalfunctionOct 22, 2020Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS PACEMAKER RECORDED VENTRICULAR TACHYCARDIA (VT) EPISODES, AND THE HEALTH CARE PROFESSIONAL (HCP) QUESTIONED IF THE EPISODES WERE TRUE OR DUE TO NOISE. TECHNICAL SERVICES (TS) REVIEWED THE EPISODES AND NOTED THAT RECENT EPISODES APPEARED TO BE TRUE VT; HOWEVER, THERE WERE PREVIOUS EPISODES WITH SMALL SIGNALS ON THE RIGHT VENTRICULAR (RV) CHANNEL BEING OVERSENSED AND CAUSING PACING INHIBITION OF APPROXIMATELY 13 SECONDS. THE PATIENT WAS ASYMPTOMATIC. TROUBLESHOOTING OPTIONS WERE DISCUSSED WITH THE HCP, AND THEY NOTED THE PATIENT WOULD BE ENROLLED IN REMOTE MONITORING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

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

  MAUDE report 10723316 ↗
• MalfunctionJan 3, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PACEMAKER STOPPED WORKING DURING PROCEDURE. THE FIELD REPRESENTATIVE CHECKED THE DEVICE AND DISCUSSED USING A MAGNET OR PROGRAMMING THE DEVICE. MOREOVER, THE PATIENT'S HEART RATE WAS IN THE 30S. AS OF THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Bradycardia

  MAUDE report 9546569 ↗
• InjuryJul 3, 2019High impedance; Over-Sensing; Pacing Problem; Device Sensing Problem; High impedance; Over-Sensing; Pacing Problem; Device Sensing Problem

  THIS REPORT IS BEING FILED AS THE EVALUATION RESULT CODES, EVALUATION CONCLUSION CODE, AND ADDITIONAL MANUFACTURER NARRATIVE HAVE BEEN UPDATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8759368 ↗
• InjuryJun 20, 2019Over-Sensing; Over-Sensing

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8718607 ↗
• MalfunctionMar 14, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PATIENT THINKS HIS HEART RATE IS DRIVEN UP WHEN HIS CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) IS IN USE. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS AND PRECAUTIONS WITH THIS PATIENT. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

  Patient problems: Apnea

  MAUDE report 8420665 ↗
• MalfunctionJan 22, 2019Low impedance; Low impedance

  IT WAS REPORTED THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD HAD AN ALERT LAST MONTH FOR LOW OUT OF RANGE PACING IMPEDANCES LESS THAN 200 OHMS IN BIPOLAR CONFIGURATION. THE LEAD WAS TESTED IN UNIPOLAR WHERE THE IMPEDANCES WERE AROUND 400 OHMS, AND 500 OHMS IN BIPOLAR. ISOMETRICS DID NOT REPRODUCE NOISE IN UNIPOLAR OR BIPOLAR, SO THE LEAD WAS PROGRAMMED BACK TO BIPOLAR. THE PATIENT WAS IN THE HOSPITAL FOR SYNCOPE DUE TO LOW BLOOD SUGAR. THE SYSTEM REMAINS IN-SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER DEVICE WAS SUBSEQUENTLY EXPLANTED AND RETURNED TO BOSTON SCIENTIFIC.

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

  MAUDE report 8268859 ↗
• InjuryJan 15, 2019High impedance; High impedance

  IT WAS REPORTED THAT PACING IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD CONNECTED TO THIS PACEMAKER WERE TRENDING UPWARDS AND REACHED GREATER THAN 2000 OHMS ON (B)(6) 2018. THIS RESULTED IN AN AUTOMATIC SAFETY SWITCH TO UNIPOLAR. THE PATIENT WAS EVALUATED IN CLINIC; THIS DEVICE THEN WAS PROGRAMMED TO PACE IN THE VENTRICLE ONLY WITH NO RESPONSE TO SENSING AND THE PATIENT WAS REFERRED FOR LEAD REVISION. SUBSEQUENTLY, THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. THIS PACEMAKER REMAINS IN SERVICE WITH THE NEW RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8250554 ↗
• InjuryNov 8, 2018High impedance; High impedance

  IT WAS REPORTED THAT THIS PACEMAKER WAS EXPLANTED DUE TO EXHIBITING A HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8050237 ↗
• InjuryOct 24, 2018Signal Artifact/Noise; Over-Sensing; Low impedance; Device Sensing Problem; Signal Artifact/Noise; Over-Sensing; Low impedance; Device Sensing Problem

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM EXHIBITED NOISE, OVERSENSING, AND LOW PACING IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPEDANCE MEASUREMENTS RANGED FROM 250 OHMS TO 450 OHMS ON THE PROGRAMMER. THE PHYSICIAN SUSPECTED THE RV LEAD WAS FRACTURED. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. THIS PACEMAKER REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 8002783 ↗
• InjuryOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 7989393 ↗
• MalfunctionJul 27, 2018High impedance; Over-Sensing; Ambient Noise Problem; Capturing Problem; High impedance; Over-Sensing; Ambient Noise Problem; Capturing Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER EXHIBITED SPIKES IN IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD. ONE VALUE WAS NOTED TO BE OUT OF RANGE AT GREATER THAN 2000 OHMS. FURTHER REVIEW SHOWED THAT THERE WAS NOISE ON THE RV CHANNEL AS WELL WHICH WAS OVERSENSED. THE NOISE WAS DUE TO THE MINUTE VENTILATION SIGNAL, SO BOSTON SCIENTIFIC TECHNICAL SERVICES RECOMMENDED PROGRAMMING THE FEATURE OFF. VARIABLE THRESHOLDS WERE ALSO OBSERVED. THE PATIENT IS NOT DEPENDENT. THE SYSTEM REMAINS IN SERVICE AND THE PATIENT IS BEING MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7725867 ↗
• MalfunctionJul 27, 2018Defective Device; Defective Device

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED BLINKING LIGHT WAS OBSERVED ON THIS PATIENT'S REMOTE MONITORING SYSTEM WHICH COULD INDICATE A RED ALERT FOR THIS SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7725853 ↗
• MalfunctionJun 28, 2018Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem; Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LIGHT ON THE REMOTE MONITORING SYSTEM WAS RED FOR AN UNKNOWN REASON. PATIENT SERVICES DISCUSSED THAT THE LIGHT MAY INDICATE INFORMATION THAT WAS RECEIVED FROM THE PATIENT'S PACEMAKER AND WAS NOT ABLE TO BE TRANSMITTED TO THE CLINIC. THE PATIENT WAS REFERRED TO THEIR CLINIC. ADDITIONAL FOLLOW-UP WAS REQUESTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7647330 ↗