DYNAGEN™ MINI ICD VR D020Recalls & reported problems

Summary

The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 00802526533860), received between Apr 22, 2016 and Sep 8, 2026 — classified as 1 death, 141 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (27 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 188 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Premature Discharge of Battery

  It was reported that the implantable cardioverter defibrillator (ICD) was interrogated and observed that it reached battery capacity depleted and recorded a Code 1003 indicative of battery voltage too low for the projected remaining capacity. Subsequently, this device was explanted and replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50660120 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A POSSIBLE POCKET EROSION DUE TO FALL, AND A SWELLING NOTED AT THE IMPLANT SITE. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD REMAINED IN SERVICE.

  Patient problems: Pocket Erosion; Swelling/ Edema

  MAUDE report 25827421 ↗
• InjuryJun 29, 2026Defibrillation/Stimulation Problem; Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CONTACTED EMERGENCY MEDICAL SERVICES (EMS) DUE TO NOT FEELING WELL. THE PATIENT SUBSEQUENTLY LOST CONSCIOUSNESS WHILE PULLING INTO THE EMERGENCY ROOM (ER) AND SPEAKING WITH PARAMEDICS AND DID NOT REGAIN CONSCIOUSNESS. THE PATIENT WAS TRANSPORTED TO A MEDICAL FACILITY WHERE DEVICE INTERROGATION WAS PERFORMED. THE INTERROGATION REVEALED THIS ICD EXHIBITED UNDERSENSING OF VENTRICULAR FIBRILLATION (VF). TECHNICAL SERVICES (TS) REVIEWED THE DATA AND DETERMINED THE INITIAL EPISODE CONSISTED OF FINE VF WITH SIGNAL AMPLITUDES BELOW THE PROGRAMMED RATE CUT OFF. INTERMITTENT TALL-SHORT CONTRIBUTED TO THE UNDERSENSING, WHICH RESULTED IN INAPPROPRIATE DETECTION WITHIN THE VENTRICULAR TACHYCARDIA (VT) ZONE. DURING THE SUBSEQUENT EPISODE, THE DEVICE DETECTED TACHYARRHYTHMIA BUT DID NOT CONSISTENTLY DELIVER THERAPY. DEVICE LOGS DOCUMENTED THAT NO THERAPY WAS DELIVERED FOR MULTIPLE THERAPY ATTEMPTS, WITH ONLY ONE ANTI-TACHYCARDIA PACING (ATP) AND ONE SHOCK DELIVERED, DESPITE THE CONTINUED ARRHYTHMIA. THERAPY ATTEMPTS WERE EXHAUSTED WHILE THE ARRHYTHMIA PERSISTED. IT WAS SUSPECTED, BUT NOT CONFIRMED, THAT A MAGN

  Patient problems: Malaise; Syncope/Fainting

  MAUDE report 25659557 ↗
• MalfunctionJun 24, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) DUE TO MYOPOTENTIAL OVERSENSING ON THE SHOCK CHANNEL. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED REPROGRAMING OPTIONS. THIS ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612028 ↗
• InjuryJun 22, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE FIELD REPRESENTATIVE WAS CONTACTED BY CLINICIAN TO CHECK THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE DATA DUE TO REPORTS OF SHOCKS. THE FIELD REPRESENTATIVE STATED THAT UPON INTERROGATION, THE DEVICE BATTERY CAPACITY WAS FOUND TO HAVE DEPLETED AND WAS NOT ABLE TO REVIEW ANY EPISODES. IT WAS NOTED PLANS FOR GENERATOR REPLACEMENT PROCEDURES WERE IN PROGRESS AND THE PATIENT WAS INCLINED TO EXPLANT THE DEVICE. SUBSEQUENTLY, ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS ICD WAS EXPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25588740 ↗
• MalfunctionJun 3, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW WAS REQUESTED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WITH HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS ON THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD. INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED, AND RV RATE SENSING HAD DROPPED SIGNIFICANTLY WITH PACE IMPEDANCE MEASUREMENTS DECREASING FROM 400 OHMS TO LESS THAN 200 OHMS. THERE WERE NUMEROUS VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) EPISODES CONTAINING NON-PHYSIOLOGIC NOISE ON THE RV RATE SENSE AND SHOCK EGMS. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS, RECOMMENDED AN IN-OFFICE CHECK TO EVALUATE RV LEAD INTEGRITY. THIS ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 25383162 ↗
• MalfunctionApr 15, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE EXHIBITING FAULT CODE 1005 PRIOR TO HIP SURGERY. TECHNICAL SERVICES (TS) RECOMMENDED SYSTEM REPLACEMENT. THIS ICD REMAINS IN SERVICE. THE PATIENT IS LOST TO FOLLOW UP, SO NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886945 ↗
• InjuryFeb 27, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 ON INTERROGATION. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468871 ↗
• InjuryFeb 26, 2026Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SIX ANTI-TACHYCARDIA PACING (ATP) THAT ACCELERATED THE HEART RHYTHM; LATER ON, THREE ROUNDS OF SHOCKS WERE DELIVERED WHICH CONVERTED THE RHYTHM. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 24456773 ↗
• InjuryFeb 25, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO BE EXHIBITING PREMATURE BATTERY DEPLETION. DIFFERING REMAINING LONGEVITY ESTIMATES HAD BEEN DISPLAYED BY THE DEVICE OVER THE PRIOR YEAR. REMOTE MONITORING WAS DISABLED. ANALYSIS OF STORED DEVICE DATA WAS UNABLE TO BE COMPLETED DUE TO LIMITED AVAILABLE DATA. DEVICE REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, THIS ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445060 ↗
• InjuryFeb 16, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY AND SHOCKS WERE DELIVERED DUE TO ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE (RVR). TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THAT THE DEVICE OPERATED AS PROGRAMMED THEREFORE RECOMMENDED REPROGRAMMING ENHANCEMENTS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24345658 ↗
• InjuryJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1007, WHICH STATES THAT THE CAPACITOR CHARGE TIME HAS EXCEEDED THE LIMIT. IN ADDITION, THE DEVICE EXHIBITED AN ALERT INDICATING THAT EXPLANT INDICATOR HAD BEEN REACHED AND THEREFORE THE REMOTE MONITORING WAS DISABLED. THIS ICD WAS SUCCESSFULLY EXPLANTED AND HAS NOT BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184307 ↗
• MalfunctionJan 21, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED. THE HEALTH CARE PROFESSIONAL (HCP) CONFIRMED THEY WERE USING THE PROGRAMMER AND THE CORRECT WAND. THE DEVICE WAS UNABLE TO BE IDENTIFIED. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING AND THE ISSUE PERSISTED. THE ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130748 ↗
• MalfunctionDec 22, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A SYNCOPAL EPISODE AND DISCOMFORT. THE ICD WAS SUSPECTED OF DELIVERING AN INAPPROPRIATE SHOCK; HOWEVER, THE SUSPECTED EPISODE COULD NOT BE VIEWED DUE TO A BATTERY CAPACITY DEPLETED (BCD) ALERT. TECHNICAL SERVICES (TS) RECOMMENDED REPLACING THE DEVICE. SUBSEQUENTLY, THIS ICD WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION (NBD). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, AND THIS ICD HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: Discomfort; Shock from Patient Lead(s); Syncope/Fainting

  MAUDE report 23864807 ↗
• InjuryNov 27, 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 THE POSSIBLE INFECTION AND FLUID DISCHARGE ISSUE. REPORTEDLY, THE PATIENT HAD WATER SAC UNDER THE ARM, AND THE ICD HAD BEEN LEAKING. THE PHYSICIAN INFORMED THAT THE PATIENT MAY HAVE A BACTERIAL INFECTION. THE PATIENT ADDED THAT THE WATER SAC HAD BEEN THERE FOR SEVERAL MONTHS. THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INFORMED THAT THE ICD WAS NOT ON ANY ADVISORIES AND DOES NOT LEAK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD REMAINS IMPLANTED. ADDITIONAL INFORMATION INDICATED THAT THE ICD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 23669049 ↗
• InjuryNov 4, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A HIGH OUT OF RANGE GRADUAL RISING PACING IMPEDANCES ON THE RIGHT VENTRICULAR (RV) CHANNEL. IT WAS ALSO NOTED THAT THERE WERE GRADUAL RISING SHOCK IMPEDANCES WITHIN NORMAL LIMITS AND NOISY SIGNALS. TECHNICAL SERVICES (TS) RECOMMENDED TO HAVE A LEAD REVISION. TACHY THERAPY WAS STATED TO BE TURNED OFF FOR THIS PATIENT. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23462290 ↗
• MalfunctionOct 21, 2025Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY AND A BATTERY DEPLETION CODE WAS RECORDED. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED REPLACEMENT. THIS ICD REMAINS IN SERVICE AND WILL NOT BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353967 ↗
• InjuryAug 27, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS THAT MAY HAVE BEEN INAPPROPRIATE. TECHNICAL SERVICES (TS) COULD NOT CONFIRM WHETHER OR NOT THIS WAS CAUSED BY VENTRICULAR TACHYCARDIA (VT) OR RAPID VENTRICULAR RESPONSE (RVR) DUE TO THE LACK OF ATRIAL LEAD PRESENT. BASED ON PRESENTING DATA, THE DEVICE WAS FUNCTIONING AS PROGRAMMED. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22907425 ↗
• MalfunctionAug 20, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 200 OHMS. THIS PATIENT WAS TO UNDERGO A MAGNETIC RESONANCE IMAGING (MRI). TECHNICAL SERVICES (TS) REVIEWED NOTING THERE WAS ONLY ONE OUT OF RANGE READING. ISOMETRICS WERE PERFORMED WHICH DID NOT PRODUCT ANY NOISE. TS NOTED ELECTROMAGNETIC INTERFERENCE (EMI) MAY BE THE CAUSE HERE. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856373 ↗
• InjuryAug 12, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SEVERAL INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP)S AND SEVERAL INAPPROPRIATE ELECTRIC SHOCKS DUE TO POSSIBLE ATRIAL FIBRILLATION (AF). IT WAS NOTED THAT THE ALL THERAPY PROGRAMMED WAS DELIVERED. CURRENTLY, THIS PRODUCT REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22789400 ↗
• MalfunctionJul 30, 2025High impedance; Over-Sensing; Delayed Charge Time; Battery Problem; High impedance; Over-Sensing; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LONGEVITY DECREASED FROM EIGHT MONTHS LAST MONTH TO ELECTIVE REPLACEMENT INDICATOR (ERI). TECHNICAL SERVICES (TS) WAS CONSULTED, NOTED TWO OUT OF RANGE SHOCK IMPEDANCE ALERTS THAT WERE GREATER THAN 125, A SIGNAL ARTIFACT MONITOR (SAM) DISABLE EPISODE WAS FOUND THAT APPEARED TO BE PROCEDURE OR ELECTROMAGNETIC INTERFERENCE (EMI) RELATED. TS PROVIDED AN ANALYSIS OF DEVICE DATA, THE ICD WAS FOUND TO BE DEPLETING NORMALLY AND THE ERI WAS DECLARED DUE TO TWO CHARGE TIMES EXCEEDING FIFTEEN SECONDS, TS NOTED THAT A NORMAL ERI TO END OF LIFE (EOL) TIMING IS APPLICABLE. TS SUGGESTED CONSIDERING RAISING THE SHOCK IMPEDANCE LIMIT. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664022 ↗
• InjuryJul 1, 2025Premature Discharge of Battery; Data Problem; Premature Discharge of Battery; Data Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WENT TO THE EMERGENCY ROOM (ER) AFTER RECEIVING MULTIPLE SHOCKS. THE HEALTH CARE PROFESSIONAL (HCP) INTERROGATED THE DEVICE AND FOUND NO EPISODES STORED. TECHNICAL SERVICES (TS) INDICATED THE DEVICE WAS AT END OF LIFE (EOL), IN THIS STATUS THE EPISODES ARE NOT STORED. IN ADDITION, ACCORDING TO THE HCP, THE LAST INTERROGATION SHOWED THAT THE DEVICE HAD APPROXIMATELY ONE YEAR REMAINING OF BATTERY CAPACITY. THEREFORE, PREMATURE BATTERY DEPLETION (PBD) WAS SUSPECTED, BUT IT WAS NOT CONCLUSIVE AS THE PATIENT HAD RECEIVED MULTIPLE SHOCKS THAT COULD HAD DEPLETED THE BATTERY CAPACITY. AS A RESULT, THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS ICD WAS ALREADY RETURNED TO BOSTON SCIENTIFIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373738 ↗
• InjuryMay 6, 2025Premature 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. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED LOW VOLTAGE FAULT. THE DEVICE HARDWARE WAS NOT DETECTING THE LOSS OF BATTERY ENERGY AND WITH THIS THE BATTERY STATUS INDICATORS WERE NOT REFLECTING THE DEPLETION AND IS INACCURATE. THE DEVICE IS MALFUNCTIONING, AND DEVICE REPLACEMENT IS RECOMMENDED. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965808 ↗
• MalfunctionMar 25, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RECEIVED BY POST MARKET QUALITY ASSURANCE FOR ANALYSIS WITHOUT ALLEGATION FROM THE FIELD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690571 ↗
• MalfunctionMar 3, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21506127 ↗

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-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