INOGEN™ EL ICD VR D141Recalls & reported problems

Summary

The FDA's MAUDE database contains 248 adverse event reports that list this exact device (DI 00802526534225), received between Apr 22, 2016 and Sep 25, 2026 — classified as 1 death, 142 injuries, 105 malfunctions.

The most frequently reported specific device problem is “High impedance” (118 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 25 most recent of 248 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903914 ↗
• MalfunctionAug 28, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50509678 ↗
• MalfunctionJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FELT A BURNING SENSATION IN THE ARMPIT AREA, EXPERIENCED A SPIKE IN BLOOD PRESSURE, AND HAD A BURNING SENSATION IN THE THROAT. THE PATIENT WAS REFERRED TO A CLINIC FOR FURTHER EVALUATION. AT THIS TIME, THE ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Burning Sensation

  MAUDE report 25449531 ↗
• InjuryJun 8, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR WHAT APPEARED TO BE AN ATRIAL DRIVEN RHYTHM. TECHNICAL SERVICES (TS) WAS UNABLE TO CONCLUSIVELY DETERMINE WHAT THE ATRIAL DRIVEN RHYTHM WAS. THIS ICD REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25429761 ↗
• InjuryJun 2, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED POTENTIALLY INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS DUE TO SUPRAVENTRICULAR TACHYCARDIA (SVT). TECHNICAL SERVICES (TS) REVIEWED AND RECOMMENDED POTENTIAL PROGRAMMING CHANGES FOR THIS DEVICE. THIS IS A SINGLE CHAMBER DEVICE SO THE ATRIAL ARRHYTHMIAS ARE PRESENT. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 25368155 ↗
• MalfunctionMay 29, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A CLINIC VISIT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO HAVE RECORDED A CODE 1005 WHICH INDICATES AN OPEN CIRCUIT CONDITION WAS DETECTED DURING SHOCK DELIVERY. THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR A CONSULT REVIEW OF THE STORED ELECTROGRAM (EGM). UPON REVIEW, THE EGM SHOWED THAT PATIENT WAS IN A TRUE VENTRICULAR TACHYCARDIA (VT) ARRHYTHMIA. THE DEVICE DELIVERED A SHOCK WHICH SLOWED THE RHYTHM RATE TO FALL BELOW RATE CUTOFFS AND PATIENT RHYTHM SELF-TERMINATED. DURING THE DELIVERY OF THE SHOCK HIGH OUT OF RANGE SHOCK IMPEDANCES WERE DETECTED ON THE RIGHT VENTRICULAR (RV) LEAD WHICH LED TO THE CODE 1005 TO BE RECORDED. TS RECOMMENDED A REPLACEMENT OF THE LEAD SYSTEM. AT THIS TIME, NO ADDITIONAL PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE ICD AND RV LEAD REMAIN IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25340884 ↗
• InjuryMay 1, 2026Adverse 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. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25061026 ↗
• MalfunctionApr 23, 2026Signal Artifact/Noise; Over-Sensing; Use of Device Problem; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED NOISE OVERSENSING IN THE RIGHT VENTRICULAR (RV) LEAD CHANNEL AS WELL AS A SIGNAL ARTIFACT MONITOR (SAM) EPISODE, WHICH LED TO THE DISABLEMENT OF THE RESPIRATORY RATE TREND FEATURE. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON REVIEW NOTED A LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENT BELOW 200 OHMS. TS ADVISED ON PROGRAMMING OPTIONS AND X-RAY EXAMINATION. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973936 ↗
• MalfunctionApr 17, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW WAS REQUESTED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM DUE TO INAPPROPRIATE TACHY THERAPY. EGM REVIEW REVEALED THAT SUPRAVENTRICULAR TACHYCARDIA (SVT) BECAME UNCORRELATED DUE TO AN ARTEFACT OBSERVED ON THE SHOCK CHANNEL, AND ANTI-TACHYCARDIA PACING (ATP) AND SINGLE SHOCK WERE DELIVERED. THE RHYTHM DID NOT CHANGE, AND THE SECOND SHOCK WAS DIVERTED. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS SCHEDULED FOR A VIRTUAL FOLLOW-UP APPOINTMENT IN (B)(6) 2026. THIS ICD SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24907109 ↗
• MalfunctionMar 11, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED SHOCK IMPEDANCE MEASUREMENTS OUT OF RANGE ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED ASSISTANCE. THIS PRODUCT REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569209 ↗
• InjuryMar 2, 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 IDENTIFIED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490501 ↗
• MalfunctionFeb 9, 2026Premature 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. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THAT THIS DEVICE POWER CONSUMPTION WAS INCREASING IN A GRADUAL FASHION. DEVICE REPLACEMENT WAS RECOMMENDED. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300119 ↗
• MalfunctionDec 17, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS WITHIN NORMAL RANGE. ADDITIONALLY, REPRODUCIBLE NOISE ON THE RV CHANNEL WAS NOTED, HOWEVER THE NOISE WAS NOT SENSED BY THE ICD. TECHNICAL SERVICES (TS) RECOMMENDED TO CONTINUE MONITORING. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832730 ↗
• InjuryDec 15, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED FIVE BURSTS OF ANTI-TACHYCARDIA PACING (ATP) AND THREE SHOCKS AS INAPPROPRIATE THERAPY FOR A SUSPECTED ARIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE (RVR), WITH THE RHYTHM CONVERTED. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23803653 ↗
• InjuryOct 28, 2025Premature 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. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THAT THIS DEVICE POWER CONSUMPTION WAS INCREASING IN A GRADUAL FASHION. TECHNICAL SERVICES (TS) RECOMMENDED DEVICE REPLACEMENT. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS ICD WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410307 ↗
• MalfunctionAug 12, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 200 OHMS. TECHNICAL SERVICES RECOMMENDED PROGRAMMING CHANGES AND DEFIBRILLATION THRESHOLD (DFT) TESTING. THE PATIENT SCHEDULED AN APPOINTMENT WITH THEIR HEALTH CARE PROFESSIONAL (HCP) AND ADJUSTMENTS WILL BE MADE AT THAT TIME. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787045 ↗
• InjuryJul 15, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE RECORD A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA WAS SENT FOR ENGINEERING ANALYSIS. ANALYSIS SHOWED THAT THE LOW VOLTAGE FAULT IS VALID AND CONFIRMED THAT THE POWER CONSUMPTION IS INCREASING IN A GRADUAL FASHION. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505166 ↗
• InjuryJul 4, 2025Adverse 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 EROSION. REPORTEDLY, A FEW WEEKS AGO, BEFORE THE SYSTEM WAS EXTRACTED, THE DEVICE SITE WAS A LITTLE SWOLLEN AND TENDER. WHEN THE PATIENT VISITED THE CLINIC, THE DEVICE STARTED TO ERODE OUT OF THE SKIN ON THE LEFT SIDE OF DEVICE POCKET. THIS ICD WAS EXPLANTED. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Discomfort; Pain; Pocket Erosion; Swelling/ Edema; Unspecified Infection

  MAUDE report 22405222 ↗
• InjuryJun 19, 2025High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED A FAULT CODE 1005 DURING DEVICE INTERROGATION, INDICATING AN OPEN CIRCUIT CONDITION. THE PATIENT HAD RECEIVED INAPPROPRIATE SHOCKS, WHICH WERE ATTRIBUTED TO OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL. IT WAS PREVIOUSLY KNOWN THAT THE PATIENT WAS IN NEED OF A LEAD REPLACEMENT. THE DETECTION OF FC 1005, REFLECTING AN IMPEDANCE GREATER THAN 145 OHMS, REINFORCES THE NECESSITY FOR A NEW LEAD. THIS SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED MENTIONING THAT THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22294074 ↗
• MalfunctionMay 12, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS FOR ITS NON BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD, SO ALERTS WERE GENERATED. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA, WITH POSSIBLE ROOT CAUSES BEEN A SPRING CONTRACT ISSUE OR A LEAD FRACTURE. TS DISCUSSED TROUBLESHOOTING OPTIONS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006224 ↗
• InjuryApr 2, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CONTACTED TECHNICAL SERVICES (TS) FOR FURTHER REVIEW OF THIS SINGLE CHAMBERED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTING ELECTROGRAM (EGM) DUE TO CONCERNS OF INAPPROPRIATE THERAPY DELIVERY. IT WAS NOTED THAT THE PATIENT WAS IN AN ARRHYTHMIA THAT IS BELIEVED TO BE ATRIAL DRIVEN BY THE HCP. UPON REVIEW, TS NOTED THAT THE RHYTHMID DEEMED THE RHYTHM TO BE UNCORRELATED LEADING TO EIGHT BURSTS OF ANTI-TACHYCARDIA PACING (ATP) AND TWO SHOCKS TO BE DELIVERED. THE SHOCKS CONVERTED THE RHYTHM. IT WAS DETERMINED THAT THE THERAPY WAS INAPPROPRIATE. TS DISCUSSED PROGRAMMING OPTIMIZATION OPTIONS WITH THE HCP. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 21758806 ↗
• InjuryMar 5, 2025Pacing Problem; Failure to Convert Rhythm; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Failure to Convert Rhythm; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) AND REQUESTED FURTHER REVIEW OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STORED VENTRICULAR EPISODE TO CONFIRM DEVICE OPERATION. UPON REVIEW, THE VENTRICULAR EPISODE SHOWED THAT THE PATIENT WAS IN A SUPRAVENTRICULAR TACHYCARDIA (SVT) RHYTHM. THE ICD INAPPROPRIATELY DELIVERED EIGHT BURSTS OF ANTI-TACHYCARDIA PACING (ATP) AND SIX SHOCKS IN ATTEMPT TO CONVERT THE RHYTHM. THERAPY WAS EXHAUSTED AND THE PATIENT REMAINED IN SVT RHYTHM. TS DISCUSSED PROGRAMMING OPTIMIZATION OPTIONS WITH THE HCP. AT THIS TIME, THE ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 21531992 ↗
• InjuryJan 28, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS, THIS WAS PRESENT AT THE LAST OFFICE INTERROGATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS ICD WAS EXPLANTED APPROXIMATELY TWO MONTHS AFTER THIS EVENT. THIS DEVICE WAS RECEIVED WITH NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21256468 ↗
• MalfunctionJan 16, 2025Signal Artifact/Noise; Over-Sensing; Use of Device Problem; Signal Artifact/Noise; Over-Sensing; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM HAD AN UNRELATED FALL AND BROKE HIS ELBOW. APPROXIMATELY TWO WEEKS LATER, THE ICD STORED 19 NO THERAPY EPISODES AND A SINGLE SIGNAL ARTIFACT MONITOR (SAM) EPISODE WHERE THE RESPIRATORY RATE TREND (RRT) SENSOR WAS DISABLED WITH A 1.5-HOUR PERIOD. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THIS CORRELATED WITH MAGNET APPLICATION DURING AN UNRELATED SURGERY. THE FOLLOWING MONTH, THE PATIENT WAS SEEN IN CLINIC FOR DEVICE-BASED TESTING AND THE DEVICE WAS OPERATING AS EXPECTED. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND THE PATIENT WAS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21171965 ↗
• InjuryJan 14, 2025Adverse 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. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS EXPLANTED.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 21149090 ↗

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-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-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-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-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• Z-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• 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