PUNCTUA™ ICD E051Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00802526480683), received between Jun 20, 2019 and Aug 25, 2026 — classified as 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (10 reports).

14 other recalls cover devices cleared under the same FDA submission (P960040); they may or may not involve this specific model.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 25, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS SHOWED THAT THE LOW VOLTAGE FAULT WAS APPROPRIATE. THE DEVICE HARDWARE IS NOT DETECTING THE LOSS OF BATTERY ENERGY. BECAUSE OF THIS, THE BATTERY STATUS INDICATORS ARE NOT REFLECTING THE DEPLETION CONDITION AND ARE INACCURATE AND SHOULD NO LONGER BE RELIED UPON TO DETERMINE THE DEPLETION STATUS OF THE DEVICE. A DEVICE REPLACEMENT WAS RECOMMENDED. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DEVICE WAS EXPLANTED AND WAS RETURNED FOR FURTHER ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183659 ↗
• InjuryMar 13, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. ALSO, THE DEVICE WAS FOUND AT BATTERY CAPACITY DEPLETED (BCD) AFTER THE RECORDED CODE 1003. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED DEVICE REPLACEMENT AS SOON AS POSSIBLE. THIS ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895117 ↗
• InjuryApr 14, 2023Premature Discharge of Battery; Telemetry Discrepancy; Battery Problem; Interrogation Problem; Premature Discharge of Battery; Telemetry Discrepancy; Battery Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) COULD NOT BE INTERROGATED. TROUBLESHOOTING STEPS WERE PERFORMED THAT WERE NOT SUCCESSFUL WHICH INCLUDED USING A MAGNET, SWITCHING PROGRAMMERS, MOVING THE PROGRAMMER FROM SHOULDER TO CHEST OVER THIS ICD, POWER CYCLING THE PROGRAMMER AND MOVING TO A DIFFERENT ROOM WITH THE PROGRAMMER. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THAT AT THE PREVIOUS INTERROGATION, THERE WERE SIGNS OF INSTABILITY IN THE BATTERY VOLTAGE WHICH IS CONSISTENT WITH INTERNAL SHORTS IN THE BATTERY. ULTIMATELY, THIS ICD WAS EXPLANTED AND REPLACED WITH A DIFFERENT DEVICE, WHICH REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16741879 ↗
• InjuryJun 7, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14628197 ↗
• InjuryJul 29, 2021Premature Discharge of Battery; Noise, Audible; Premature Discharge of Battery; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED CODE 1003 INDICATIVE OF VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY. SAVE TO DISK DATA WAS SENT TO ENGINEERING FOR REVIEW. DEVICE WAS EXPLANTED AND RETURNED TO BOSTON SCIENTIFIC. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250559 ↗
• InjuryApr 3, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE DECLARED A FAULT CODE-1003 INDICATIVE TO VOLTAGE TOO LOW FOR REMAINING CAPACITY. THIS DEVICE WAS EXPLANTED AT A SURGICAL INTERVENTION AND A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9922611 ↗
• InjuryJan 9, 2020Premature Discharge of Battery; Device Displays Incorrect Message; Noise, Audible; Premature Discharge of Battery; Device Displays Incorrect Message; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE PULSE GENERATOR EMITTED BEEPING TONES AND AN ALERT FOR VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY. A REPLACEMENT SURGERY WILL BE SCHEDULED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 9571568 ↗
• InjurySep 19, 2019Premature Discharge of Battery; Device Displays Incorrect Message; Premature Discharge of Battery; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 WHICH IS INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED DEVICE REPLACEMENT. THIS DEVICE WAS EXPLANTED, REPLACED, RETURNED AND ANALYZED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9088762 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO INFECTION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 8862511 ↗
• InjuryJun 20, 2019Premature Discharge of Battery; Device Displays Incorrect Message; Premature Discharge of Battery; Device Displays Incorrect Message

  IT WAS REPORTED YOU THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8718600 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P960040. One submission often covers many models, so check the product and lot details in each record.

• Z-1670-2022 · Jul 7, 2022 · Open, Classified
  The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all
• Z-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, Sterile.
• Z-0079-2018 · Oct 4, 2017 · Terminated
  VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharma
• Z-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, Sterile.
• Z-1555-2010 · Mar 15, 2010 · Terminated
  Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter Defibrillator (ICDs) are designed to detect and termina
• Z-0610-2010 · Dec 1, 2009 · Terminated
  Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethyle
• Z-1621-2009 · Mar 4, 2009 · Terminated
  GUIDANT VITALITY DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model T175 VR; 2EL ICD Model T167 DR; 2 EL ICD Model T177 VR; DS Model T125 DR. Implantable Cardi
• Z-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• Z-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• Z-0051-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, T177). Implantable Cardioverter Defibrillator, ICD. Guidant Corporation, 4100 Hamline A
• Z-0050-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant VITALITY DR HE (Model T180), Implantable Cardioverter Defibrillators (ICD). Guidant Corpor
• Z-1297-06 · Jun 24, 2006 · Terminated
  Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide.
• Z-1292-06 · May 15, 2006 · Terminated
  Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ven
• Z-0828-06 · Apr 7, 2006 · Terminated
  Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 551