INCEPTA CRT-DRecalls & reported problems across all models

We found 3 models of INCEPTA CRT-D by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 372 adverse event reports in the FDA's MAUDE database, received between May 8, 2014 and Apr 15, 2026 — classified as 4 deaths, 237 injuries, 131 malfunctions.

The most frequently reported specific device problem is “High impedance” (97 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 INCEPTA CRT-D problems

INCEPTA CRT-D models

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

• INCEPTA™ CRT-D N161

  Implantable pulse generator, pacemaker (non-CRT)
  2 deaths168 reports
• INCEPTA™ CRT-D N160

  Implantable pulse generator, pacemaker (non-CRT)
  1 death108 reports
• INCEPTA™ CRT-D N164

  Implantable pulse generator, pacemaker (non-CRT)
  1 death96 reports

Recent INCEPTA CRT-D adverse event reports

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

• InjuryApr 15, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885083 ↗
• InjuryFeb 11, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED AN ALERT AND WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316703 ↗
• MalfunctionJan 26, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED OVERSENSED NOISE ON THE RIGHT ATRIAL (RA) CHANNEL, RESULTING IN INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183504 ↗
• InjuryDec 20, 2025Delayed Charge Time; Battery Problem; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WITH 8 MONTHS OF REMAINING LONGEVITY, HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) AND IS NOW AT END OF LIFE (EOL). TECHNICAL SERVICES (TS) REVIEWED THE CASE AND CONFIRMED THAT ERI WAS TRIGGERED DUE TO CHARGE TIME (CT). TS ALSO STATED THAT THE PATIENT LIKELY EXPERIENCED A CONNECTION PROBLEM; OTHERWISE, THE ALERT WOULD HAVE BEEN SENT VIA LATITUDE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860155 ↗
• InjuryOct 24, 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 THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23386396 ↗
• InjuryOct 8, 2025High impedance; Inappropriate/Inadequate Shock/Stimulation; High impedance; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCK THERAPY WITH NO THERAPY EXHAUSTION. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS, WHICH WERE REPRODUCIBLE VIA PACING SYSTEM ANALYZER (PSA) TESTING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS ICD DELIVERED INAPPROPRIATE SHOCK FOR EITHER SINUS TACHYCARDIA OR SUPRAVENTRICULAR TACHYCARDIA. THE RHYTHM WAS 1:1 AND ATRIAL DRIVEN. A SUBSEQUENT INAPPROPRIATE SHOCK WAS OBSERVED AT THE TIME OF REPORT. TECHNICAL SERVICES (TS) RECOMMENDED THAT THE HEALTH CARE PROFESSIONAL (HCP) CONSULT WITH CARDIOLOGY FOR FURTHER EVALUATION AND REPROGRAMMING OPTIONS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23243531 ↗
• InjurySep 2, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THERAPIES WERE TURNED OFF SPECIFICALLY BRADY AND TACHY THERAPIES. AS OF THIS TIME, THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939175 ↗
• InjuryAug 20, 2025Delayed Charge Time; Battery Problem; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A LONGEVITY OF 11 MONTHS AND DROPPED TO ELECTIVE REPLACEMENT INDICATOR (ERI) IN A SPAN OF 2 MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONFIRMED THAT THE DEVICE HAD A CAPACITOR REFORM AND CHARGE TIME (CT) EXCEEDED 15 SECONDS. THE CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED. A NEW CRT-D WITH A DIFFERENT MODEL WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22857377 ↗
• InjuryJun 5, 2025Signal Artifact/Noise; Premature Discharge of Battery; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Premature Discharge of Battery; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS PREVIOUSLY IMPLANTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM HAD A FRACTURED RIGHT VENTRICULAR (RV) LEAD WHICH EXHIBITED NOISE WITH OVERSENSING AND DELIVERED INAPPROPRIATE TACHY THERAPY. ADDITIONALLY, THIS LEAD ISSUE RESULTED IN INCREASED BATTERY POWER CONSUMPTION. IT WAS NOTED THAT THIS LEAD ISSUE OCCURRED BACK IN 2020, WHEN IT WAS DIFFICULT TO FIND AN AVAILABLE HOSPITAL ROOM IN ORDER FOR THE PATIENT TO UNDERGO A LEAD REVISION. IT WAS BELIEVED THAT THE PATIENT HAD FIVE LEADS IN HIS BODY AT ONE POINT. SOME OF THOSE LEADS HAD BEEN REVISED, AND A DEFIBRILLATION LEAD HAD BEEN IMPLANTED FOR A DEVICE WITH THREE LEADS. AS A RESULT OF THESE ISSUES, THE PATIENT REPORTED SEVERE DISCOMFORT/PAIN/DISTRESS. THIS CRT-D WAS EXPLANTED AND REPLACED WITH A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DURING A THERAPY DOWNGRADE, AND ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE AT THAT TIME MENTIONED THAT THE PATIENT NO LONGER NEEDED A DEFIBRILLATOR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D WAS RETURNED FOR ANALYSIS.

  Patient problems: Discomfort; Pain; Shock from Patient Lead(s)

  MAUDE report 22150657 ↗
• MalfunctionJun 4, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS REACHED EXPLANT INDICATOR AND EXHIBITED OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS. THE PLAN FOR THIS PATIENT IS CONTINUED MONITORING. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143563 ↗
• MalfunctionJun 2, 2025Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT DURING A NORMAL BATTERY DEPLETION DEVICE REPLACEMENT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS HAVING INTERROGATION ISSUES. IT WAS NOTED THAT THE CONNECTION WAS SLUGGISH AND COULD NOT BE MAINTAINED WITHOUT PHYSICAL PROXIMITY TO THE DEVICE. MULTIPLE PROGRAMMERS AND TELEMETRY WANDS WERE ATTEMPTED BUT DID NOT RESOLVE THIS. THIS DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THIS DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124501 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE CRT-D WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22093624 ↗
• InjuryApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. NO OTHER INFORMATION WAS PROVIDED. THIS RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860579 ↗
• MalfunctionApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860098 ↗
• InjuryApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THE ASSOCIATED RV LEAD WAS TAKEN OUT OF SERVICE; HOWEVER, THIS DEVICE REMAINED IN SERVICE AT THE TIME OF PROCEDURE AND WAS SUBSEQUENTLY REMOVED FROM SERVICE AT A LATER DATE TO AN UNRELATED REASON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856449 ↗

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