PUNCTUA™ ICD E050Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00802526480676), received between Nov 28, 2018 and Apr 16, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9922814 ↗
• MalfunctionApr 20, 2019Unexpected Therapeutic Results; Under-Sensing; Unexpected Therapeutic Results; Under-Sensing

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THERE WAS TWO UNTREATED EPISODES NOTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). MOREOVER, THERE WERE AN UNDERSENSED BEATS NOTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) THEN DISCUSSED ADJUSTING SENSITIVITY AND SUGGESTED MEASURING THE SIGNAL AMPLITUDE ON THE PROGRAMMER. TS ALSO DISCUSSED COULD CONSIDER GOING BACK TO NOMINAL DURATION SETTINGS. FURTHER, THE TS EXPLAINED THAT THE DEVICE WOULD NOT DIVERT TWICE IN A ROW. THE ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8534183 ↗
• InjuryNov 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SYSTEM WAS EXPLANTED DUE TO INFECTION WITH SEPSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 8112676 ↗

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-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-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-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