PUNCTUA ICDRecalls & reported problems across all models

We found 4 models of PUNCTUA ICD by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Oct 29, 2018 and Sep 4, 2026 — classified as 53 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (37 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 PUNCTUA ICD problems

PUNCTUA ICD models

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

• PUNCTUA™ ICD E053

  Implantable pulse generator, pacemaker (non-CRT)
  38 reports
• PUNCTUA™ ICD E051

  Implantable pulse generator, pacemaker (non-CRT)
  16 reports
• PUNCTUA™ ICD E052

  Implantable pulse generator, pacemaker (non-CRT)
  9 reports
• PUNCTUA™ ICD E050

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

Recent PUNCTUA ICD adverse event reports

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

• InjurySep 4, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50621100 ↗
• MalfunctionAug 25, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited high out of range shock impedance measurements for its right ventricular (RV) lead. Technical Services (TS) was consulted and discussed stored data as well as measurements trends, with TS recommending the measurements to continue to be monitored. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50423819 ↗
• MalfunctionApr 16, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DIFFICULTIES TO INTERROGATE. THE HEALTH CARE PROFESSIONAL (HCP) CONSULTED FOR RECOMMENDATIONS TO INTERROGATE THIS DEVICE, TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA, CONFIRMED THE DEVICE IS SUPPORTED BY THE PROGRAMMER AND RECOMMENDED TO HOVER THE WAND IN A CIRCULAR MOTION. THE HCP WAS REFERRED TO THE LOCAL FIELD REPRESENTATIVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899195 ↗
• InjuryJan 30, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THAT THE BATTERY VOLTAGE RECENTLY BEGAN DROPPING IN AN IRREGULAR FASHION WHICH COULD POSSIBLY BE RELATED TO AN INTERNAL ELECTRICAL SHORT OF THE BATTERY. DEVICE REPLACEMENT WAS RECOMMENDED. THIS ICD REMAINS IN-SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS ICD WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222346 ↗
• MalfunctionAug 14, 2025High impedance; High impedance

  IT WAS REPORTED THAT A SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 200 OHMS IN TRIAD CONFIGURATION, WAS OBSERVED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IMPEDANCE TREND DATA SHOWED STABLE VALUES. THIS PATIENT WAS EVALUATED IN THE CLINIC IN WHICH IS WAS REVEALED THAT IMPEDANCE TESTING OCCURRED DURING PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION RESULTING IN THE OUT OF RANGE MEASUREMENT. TESTING CONFIRMED IMPEDANCES WERE BACK IN THE NORMAL RANGE. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812599 ↗
• MalfunctionMay 12, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED RIGHT VENTRICULAR (RV) HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED, DISCUSSED ONE NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODE THAT HAD NOISE THAT WAS OVERSENSED. TECHNICAL SERVICES (TS) OPTIONS FOR TROUBLE SHOOTING TO DETERMINE IF IT IS A SPRING CONTACT ANOMALY OR LEAD FRACTURE. THIS PACEMAKER SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006717 ↗
• 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. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853466 ↗
• MalfunctionMar 10, 2025Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT DURING A CLINIC VISIT, THE HEALTH CARE PROFESSIONAL (HCP) EXPERIENCED DIFFICULTIES INTERROGATING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE. THE HCP CALLED TECHNICAL SERVICES (TS) AND REQUESTED TROUBLESHOOTING ASSISTANCE. TROUBLESHOOTING EFFORTS WERE ATTEMPTED, HOWEVER WERE UNSUCCESSFUL BECAUSE PROGRAMMER STILL WAS UNABLE TO READ DEVICE DATA. TS RECOMMENDED THE HCP TO CONTACT THE LOCAL FIELD REPRESENTATIVE FOR FURTHER ASSISTANCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD AND PROGRAMMER REMAIN IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560705 ↗
• InjuryFeb 13, 2025Premature Discharge of Battery; Noise, Audible; Premature Discharge of Battery; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY AND EMITTED A TONE PATTERN WITH 1.5 YEARS BATTERY REMAINING. THIS ICD WAS SUBMITTED FOR ENGINEERING ANALYSIS WHICH RESULTED THAT THIS DEVICE EXHIBITED A LOW VOLTAGE AND THE POWER CONSUMPTION WAS INCREASING IN GRADUAL FASHION. THIS APPEARED CONSISTENT WITH CAPACITOR DEGRADATION DUE TO HYDROGEN GAS CONTENT IN THE SEALED DEVICE ATMOSPHERE. DEVICE REPLACEMENT WAS RECOMMENDED. THIS ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375460 ↗
• InjuryNov 7, 2024High impedance; High impedance

  IT WAS REPORTED THAT, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCK LEAD IMPEDANCES. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. AT THIS TIME THE RV LEAD HAS BEEN EXPLANTED, AS WELL AS THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH AN ALLEGATION OF MALFUNCTION. THE ICD HAS BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20634690 ↗
• InjuryOct 3, 2024Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY LONGEVITY DROPPED FROM 1.5 YEARS TO 3 MONTHS IN A SPAN OF 3 MONTHS. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS RESULT DID NOT SHOW A LOW VOLTAGE FAULT, BUT THIS DEVICE POWER CONSUMPTION IS INCREASING IN A GRADUAL FASHION AND EXHIBITED PREMATURE BATTERY DEPLETION (PBD). DEVICE REPLACEMENT WAS RECOMMENDED. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20365241 ↗
• MalfunctionSep 15, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing

  IT WAS REPORTED THAT REVIEW OF DEVICE INTERROGATION WAS REQUESTED. THE REVIEW IS SIGNIFICANT FOR A LARGE NUMBER OF STORED VENTRICULAR EVENTS AND SOME ATRIAL TACHYCARDIA RESPONSE (ATR) EVENTS. OTHER EPISODES WERE NON-SUSTAINED. HOWEVER, THERE WAS ONE EVENT WITH DELIVERY OF ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FOR APPARENT ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE SHOCK TERMINATED THE ARRHYTHMIA. THERE WAS UNDERSENSING OF AF, WHICH MAY HAVE ADDED TO THE NUMBER OF V EVENTS STORED DUE TO THE RVR. THE CLINICAL OBSERVATIONS WERE DOCUMENTED, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS SUBSEQUENTLY EXPLANTED FOR NORMAL BATTERY DEPLETION AND WAS RETURNED FOR ROUTINE EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia; Shock from Patient Lead(s)

  MAUDE report 20220966 ↗
• InjurySep 12, 2024Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS PATIENT IS NOT FOLLOWED REMOTELY AND A NORMAL FOLLOW UP VISIT 7 MONTHS AGO IDENTIFIED THERE WAS 9 MONTHS REMAINING LONGEVITY. HOWEVER, A FEW WEEKS LATER THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI). A FULL EVALUATION REPORT FROM THE DATE OF THE INTERROGATION WAS NOT AVAILABLE AND DISK ANALYSIS WAS NOT PERFORMED. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED ERI COULD HAVE BEEN TRIGGERED DUE TO CHARGE TIME. THE PREVIOUS LONG EVALUATION SESSION COUPLED WITH A ROUTINE CAPACITOR REFORMATION RIGHT AWAY THAT MADE THE AVERAGE POWER CONSUMPTION VERY HIGH FOR THAT WEEK COULD HAVE DECLARED EXPLANT TO MAINTAIN THE 90 DAYS REPLACEMENT INTERVAL. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND IS EXPECTED TO BE RETURNED FOR EVALUATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20202662 ↗
• MalfunctionJul 23, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) OVERSENSED NOISE, WHICH RESULTED IN INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) AND VENTRICULAR ARRHYTHMIA EPISODES. TECHNICAL SERVICES (TS) REVIEWED THE EVENTS AND INDICATED THE NOISE APPEARED TO BE FROM ELECTROCAUTERY. THE HEALTH CARE PROFESSIONAL (HCP) CONFIRMED THE STORED EVENTS OCCURRED DURING A MEDICAL PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809215 ↗
• MalfunctionMay 20, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNDERSENSING OF SOME BEATS. WHICH WAS LIKELY DUE TO THE ATRIAL GAIN CONTROL (AGC) DECAY PROFILE STEPPING OVER THE R-WAVES. NO THERAPY WAS NEEDED OR APPROPRIATE AND NO PROGRAMMING CHANGES WERE RECOMMENDED. CURRENTLY, THIS ICD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355848 ↗

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