PUNCTUA™ ICD E053Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00802526480706), received between Oct 29, 2018 and Jan 30, 2026 — classified as 33 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (24 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryDec 25, 2023Adverse 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 SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 18390529 ↗
• InjuryDec 30, 2022Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED AN FC 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY AND OBSERVED THAT THE BATTERY WAS INACCURATE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THIS DEVICE WAS NOT ON THE LOW VOLTAGE CAPACITOR ADVISORY, HOWEVER, SIMILAR FAILURE RATES WERE NOTED. TS ALSO DISCUSSED THAT WITHOUT ANALYSIS AN EMERGENT CHANGEOUT IS RECOMMENDED PER FAULTS AND ACTIONS. A DEVICE DATA FOR ANALYSIS WAS ADVISED WHICH COULD GIVE CAUSE AND GUIDANCE FOR CHANGEOUT TIMING. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16076727 ↗
• InjuryMay 28, 2022Signal Artifact/Noise; High impedance; Pacing Problem; Low impedance; Signal Artifact/Noise; High impedance; Pacing Problem; Low impedance

  IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A SHOCK IMPEDANCE MEASUREMENT OF ZERO OHMS ON A NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD AS A RESULT OF ELECTROMAGNETIC INTERFERENCE (EMI). TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED PROGRAMMING AND TROUBLESHOOTING RECOMMENDATIONS. THE PLAN WAS TO BRING THE PATIENT IN FOR FURTHER EVALUATION AT A LATER DATE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT WAS BROUGHT INTO THE CLINIC FOR FURTHER EVALUATION. IT WAS NOTED THAT THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE WHICH WAS REPRODUCIBLE THROUGH ISOMETRIC MANEUVERS. ADDITIONALLY, PACEMAKER MEDIATED TACHYCARDIA (PMT) WAS ALSO NOTED AS A RESULT OF THE NOISY SIGNALS. ADDITIONALLY, DURING TESTING OF THE NON-BOSTON SCIENTIFIC RV LEAD, A HIGH OUT OF RANGE (OOR) SHOCK IMPEDANCE MEASUREMENT WAS RECORDED. THE HEALTH CARE PROFESSIONAL (HCP) HAD NOTED THAT THE PATIENT WAS SEEN IN CLINIC APPROXIMATELY ONE WEEK PRIOR AFTER THE FIRST OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WAS OBSERVED. THE HCP REPORTED THE PATIENT WAS SHOWERING AT THE TIME OF THE OOR MEASUREMENT. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED TROUBLESHOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14538309 ↗
• MalfunctionApr 9, 2022High impedance; Noise, Audible; High impedance; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCES MEASURING 125 OHMS ON THE RIGHT VENTRICULAR (RV) LEAD. AS A RESULT, THE DEVICE EMITTED BEEPING TONES. IT WAS NOTED THERE WAS NO NOISE OBSERVED ON THE PRESENTING ELECTROGRAM. TECHNICAL SERVICES RECOMMENDED TO HAVE THE DEVICE CHECKED WITH A PROGRAMMER TO STOP THE BEEPING, RAISING THE UPPER RATE LIMIT TO 150 OR GREATER AND TO PERFORM A COMMANDED 41J SHOCK. AT THIS TIME, THE ICD AND RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068860 ↗
• MalfunctionApr 6, 2022Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS DEVICE DELIVERED MULTIPLE INAPPROPRIATE ELECTRIC SHOCKS AND MULTIPLE ROUNDS OF ANTITACHYCARDIA PACING (ATP) DUE TO AN ATRIAL DRIVE ARRHYTHMIA. THIS DEVICE DELIVERED INAPPROPRIATE THERAPY IN TWO SEPARATE EPISODES. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 14033557 ↗
• InjuryJul 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PACEMAKER SYSTEM WAS EXPLANTED. NO PRODUCT ALLEGATIONS HAVE BEEN RECEIVED AT THIS TIME. A NEW SYSTEM WAS SUCCESSFULLY PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12113773 ↗
• InjuryJul 2, 2021Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Noise, Audible; Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; Noise, Audible

  IT WAS REPORTED THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO SINUS TACHYCARDIA AS SHE WAS CARRYING GROCERIES UP A FLIGHT OF STAIRS. THE PATIENT INDICATED SHE COULD HEAR TONES FROM THE DEVICE PRIOR TO THE SHOCK BEING DELIVERED AND HAD POST TRAUMATIC STRESS DISORDER (PTSD) FROM THE SHOCK. TECHNICAL SERVICES (TS) WAS CONTACTED AND NOTED BEEP DURING CAPACITOR CHARGE WAS PROGRAMMED OFF ON THE SAME DAY AS THE SHOCK. THE FIELD REPRESENTATIVE INDICATED THEY BELIEVE IT WAS ON PRIOR TO THAT. THE FIELD REPRESENTATIVE DISCUSSED THE SITUATION WITH THE CLINIC AND REPROGRAMMING OCCURRED. THE FIELD REPRESENTATIVE INDICATED THAT THE PTSD WAS GIVEN TO HIM AS NOTES FROM THE PHYSICIAN. THE ICD REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Anxiety; Electric Shock

  MAUDE report 12112218 ↗
• InjuryJan 21, 2021Adverse 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 POCKET INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 11211735 ↗
• InjuryJan 2, 2021Premature Discharge of Battery; Noise, Audible; Premature Discharge of Battery; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EMITTED BEEPING TONES AND 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. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 11104746 ↗
• InjuryJan 2, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION (PBD) BEHAVIOR. THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. EVENTUALLY, THIS DEVICE WAS SURGICALLY EXPLANTED, REPLACED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 11104416 ↗
• InjuryDec 18, 2020Adverse 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. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 11040274 ↗
• InjuryOct 2, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 MESSAGE INDICATOR THAT THE BATTERY VOLTAGE IS TOO LOW FOR THE PROJECTED REMAINING CAPACITY. THE BATTERY WAS SUSPECTED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 10621491 ↗
• InjuryApr 17, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED AS IT DECLARED A 1003 CODE INDICATIVE TO VOLTAGE TOO LOW FOR REMAINING CAPACITY. DEVICE WAS RETURNED AND ANALYZED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9974454 ↗
• InjuryApr 15, 2020Premature Discharge of Battery; Noise, Audible; Premature Discharge of Battery; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR 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. THE DEVICE EMITTED BEEPING TONES ASSOCIATED TO THE CODE 1003. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE WAS ALREADY REPLACED AND RETURNED FOR ANALYSIS. FOLLOW UPS WERE INCREASED AS A RESULT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 9965790 ↗
• InjuryFeb 4, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION. DEVICE WAS RETURNED AND ANALYZED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9666422 ↗
• InjuryJan 28, 2020Premature Discharge of Battery; Device Displays Incorrect Message; Premature Discharge of Battery; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR 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 REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9638394 ↗
• InjuryJan 6, 2020Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message; Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS DEVICE HAD RECORDED A CODE 1003 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. THERE WAS ALSO OBSERVATIONS OF GRADUAL RISE IN HIGH OUT OF RANGE SHOCK LEAD IMPEDANCES OVER THE PAST YEAR, WHERE CALCIFICATION WAS A CONSIDERED FACTOR DUE TO EXTREME CALCIFICATION IN THE POCKET. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED WHERE VENTRICULAR TACHYCARDIA (VT) WAS NOT CONVERTED, AND THE DELIVERED SHOCK THERAPY TRIGGERED A CODE 1005 FOR OPEN CIRCUIT. SUBSEQUENTLY, THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 9550183 ↗
• InjuryJan 3, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  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 RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9547817 ↗
• InjuryJul 18, 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 WAS EXPLANTED DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 8805080 ↗
• MalfunctionJun 20, 2019Premature Discharge of Battery; Device Displays Incorrect Message; Noise, Audible; Premature Discharge of Battery; Device Displays Incorrect Message; Noise, Audible

  ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED AFTER RECORDING A CODE 1003. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8720369 ↗
• InjuryJun 20, 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) DEVICE RECORDED A CODE 1003 WHICH IS 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 REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8719094 ↗

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-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-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, 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