INOGEN™ MINI ICD VR D011Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 00802526533808), received between Jul 12, 2016 and Apr 17, 2025 — classified as 1 death, 43 injuries, 28 malfunctions.

The most frequently reported specific device problem is “High impedance” (25 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 72 reports, in the reporter's own words as published by the FDA.

• 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 WAS EXPLANTED AT A LATER TIME FOR AN UNRELATED REASON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854088 ↗
• MalfunctionMar 28, 2024High impedance; Delayed Charge Time; High impedance; Delayed Charge Time

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE INVOLVED RIGHT VENTRICULAR (RV) LEAD IS A NON BOSTON SCIENTIFIC PRODUCT. THE PATIENT WAS FURTHER EVALUATED AND BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) NOTED INCREASED CHARGE TIMES AND THE DEVICE AT ELECTIVE REPLACEMENT INDICATOR (ERI). REPROGRAMMING OPTIONS WERE DISCUSSED WITH THE HEALTH CARE PROFESSIONAL (HCP). NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991894 ↗
• MalfunctionOct 4, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT OPERATIONAL IN THE LAST 7 YEARS DUE TO LEAD BREAKAGES AND THE PATIENT'S HEART HAS IMPROVED. MOREOVER, THIS DEVICE BEGAN BEEPING AND A CLINICIAN INSTRUCTED THE PATIENT TO CONTACT BSC PERSONNEL. AS OF THIS TIME, THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17870000 ↗
• InjuryAug 29, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS GETTING LOW. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED CONTACTING DEVICE CLINIC. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646792 ↗
• InjuryAug 10, 2023High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM HAD RECEIVED NUMEROUS SHOCKS. UPON INTERROGATION, THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD AND ICD HAD RECORDED A CODE 1005, INDICATIVE OF AN OPEN CIRCUIT CONDITION DETECTED UPON SHOCK DELIVERY DUE TO A HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT GREATER THAN 145 OHMS. THE PATIENT RECEIVED AT LEAST 12 SHOCKS ON JULY 27, 2023, AS INTERROGATION REVEALED THE CODE 1005 MESSAGE ON THE PROGRAMMER SCREEN 12 TIMES. IT WAS NOT POSSIBLE TO VIEW EPISODES TO ASSESS WHETHER THERAPY WAS APPROPRIATE AND/OR EXHAUSTED, AS THE ICD HAD REACHED END OF LIFE (EOL) ON APRIL 28, 2023. TECHNICAL SERVICES (TS) REVIEWED TROUBLESHOOTING OPTIONS. THIS ICD SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 17506292 ↗
• InjuryMar 23, 2023Signal Artifact/Noise; Over-Sensing; Pacing Problem; Impedance Problem; Migration; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Impedance Problem; Migration

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD MIGRATED APPROXIMATELY 5CM BELOW THE INCISION SITE. IT WAS NOTED THAT THE PATIENT HAD A PREVIOUS POCKET REVISION, HOWEVER IT WAS UNCLEAR WHEN THE REVISION OCCURRED OR WHETHER THE REVISION WAS PERFORMED ON THIS PARTICULAR DEVICE. MEDICAL RECORDS INDICATE THIS DEVICE WAS ORIGINALLY IMPLANTED SUBPECTORAL. IN ADDITION, THERE WAS OVERSENSED NOISE WITH PACING INHIBITION AND DECREASING IMPEDANCE MEASUREMENTS OBSERVED ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED WITH ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) LEAD. THERE WAS NO INDICATION OF GREATER THAN TWO SECONDS. ALL LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. AN X-RAY WAS TAKEN WHICH SHOWED A LOOP IN THE RV LEAD BODY THAT APPEARS TO BE BETWEEN THE SHOCKING COILS, AND INSULATION BREACH WAS SUSPECTED AS WELL. SUBSEQUENTLY, THIS ICD SYSTEM WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THE PATIENT WAS BRADYCARDIC AND UPGRADED TO A DUAL CHAMBER DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16605043 ↗
• InjuryFeb 28, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE EXHIBITED CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT YET BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456446 ↗
• InjuryJan 12, 2023Premature 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. THIS DEVICE WAS SUCCESSFULLY EXPLANTED AND IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16145918 ↗
• InjuryDec 19, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION (PBD). THE DEVICE WAS EXPLANTED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005123 ↗
• InjuryDec 6, 2022Connection Problem; Impedance Problem; Connection Problem; Impedance Problem

  IT WAS REPORTED THAT DURING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGE OUT PROCEDURE, SPRING CONTACT TO RING ELECTRODE IMPEDANCE SPIKES WERE NOTED ON A NON BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. NO NOISE WAS NOTED. THIS LEAD WAS PLUGGED INTO THE NEWLY IMPLANTED DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS EXPLANTED AND REPLACED AND THE RV LEAD REMAINS IN SERVICE. IT IS NOT EXPECTED TO RECEIVE THIS DEVICE FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923625 ↗
• MalfunctionSep 22, 2022Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE ACROSS MULTIPLE EPISODES ON THE SAME DAY. DEVICE THERAPY WAS NOT EXHAUSTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE EPISODES AND NOTED THAT THE RHYTHM ID (RID) IS INITIALLY CORRELATED SO THIS COULD BE DUE TO AN ATRIAL-DRIVEN ARRHYTHMIA. ALSO, THE VENTRICULAR BEAT TO BEAT INTERVALS ARE ALSO IRREGULAR. AT THE POINT OF DEVICE THERAPY, RID BECOMES UNCORRELATED. TS ALSO NOTED THAT THE DEVICE THERAPY ZONE IS CURRENTLY PROGRAMMED FOR A HEART RATE THAT IS QUITE LOW. THE CURRENT PRESENTING ELECTROGRAM INDICATES THE PATIENTS RATE HAS SLOWED. THE CLINICIAN INDICATED THEY WERE GOING TO DISCUSS THE SITUATION WITH THE PHYSICIAN. THE DEVICE REMAINS IN-SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 15465591 ↗
• InjuryAug 17, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOWED ERROR CODES 1004 AND 1007, AND THE DEVICE WAS OPERATING IN SAFETY MODE. THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED DEVICE WAS EXPECTED TO BE RETURNED FOR ANALYSIS. TECHNICAL SERVICES DISCUSSED THE ERROR CODES WERE FOR A SHOCK INTO A SHORTED CONDITION (1004) AND CHARGE TIME OUT (1007).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242629 ↗
• InjuryJul 13, 2022Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS DEVICE WAS SUSPECTED OF EXHIBITING PREMATURE BATTERY DEPLETION BEHAVIOR. THE BATTERY LONGEVITY DECREASED FROM 3 YEARS TO ELECTIVE REPLACEMENT INDICATOR IN APPROXIMATELY 4 MONTHS TIME. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS EXPECTED FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15003271 ↗
• MalfunctionApr 7, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THIS PATIENT RECEIVED 3 SHOCKS WHILE SHOVELING SNOW. THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS AT END OF LIFE (EOL) AND COULD NOT BE INTERROGATED TO DETERMINE IF THE SHOCKS WERE APPROPRIATE OR INAPPROPRIATE. THE DEVICE WAS EXPLANTED AND RETURNED FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14048967 ↗
• InjuryApr 7, 2022Premature Discharge of Battery; Noise, Audible; Premature Discharge of Battery; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EMITTED AUDIBLE TONES, AND RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. TECHNICAL SERVICES REVIEW OF DEVICE DATA CONFIRMED THE POWER CONSUMPTION HAD BEEN GRADUALLY INCREASING AND IS HIGHER THAN EXPECTED. AS A RESULT, DEVICE REPLACEMENT WITHIN 90 DAYS OR MORE FREQUENT MONITORING 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 14047621 ↗
• InjuryJan 27, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ADMITTED DUE TO COMPLICATIONS OF CHANGE OUT. UPON DEVICE INTERROGATION, THE DEVICE REACHED BATTERY CAPACITY DEPLETED SEVERAL MONTHS AGO. TO DATE, THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13376499 ↗
• InjuryJan 1, 2022Adverse 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. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 13138385 ↗
• MalfunctionOct 22, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO BE PREMATURELY DEPLETING. TECHNICAL SERVICES (TS) DISCUSSED THE DEVICE CHARGE TIME IS A SECONDARY INDICATOR OF ELECTIVE REPLACEMENT AND RECOMMENDED DEVICE REPLACEMENT WITHIN THE NEXT NINETY DAYS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686467 ↗
• InjuryOct 19, 2021Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Delayed Charge Time; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Delayed Charge Time

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REVERTED TO SAFETY CORE MODE UNEXPECTEDLY. TECHNICAL SERVICES (TS) DISCUSSED DEVICE FUNCTIONALITY AND RECOMMENDED DEVICE REPLACEMENT DUE TO LIMITED THERAPY AVAILABLE IN SAFETY MODE. SURGICAL INTERVENTION WAS UNDERTAKEN. THE ICD WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE IS RETURNED, THIS REPORT WILL BE UPDATED WITH PERTINENT INFORMATION, UPON COMPLETION OF PRODUCT ANALYSIS.

  Patient problems: Electric Shock

  MAUDE report 12660948 ↗
• MalfunctionJul 23, 2021High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. FURTHER EVALUATION IS EXPECTED AT THE NEXT FOLLOW UP. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217976 ↗
• InjuryJul 22, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT FAULT CODE 1007 APPEARED FOR THE DEVICE. THE DEVICE WAS REPLACED AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215542 ↗
• InjuryMay 6, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION (PBD). THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787402 ↗
• InjuryApr 28, 2021Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Low impedance; Signal Artifact/Noise; Incorrect, Inadequate or Imprecise Result or Readings; Low impedance

  IT WAS REPORTED DURING A ROUTINE FOLLOW UP APPOINTMENT THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE EXHIBITED CODE 1004, INDICATIVE OF SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS RESULTING IN A SHORTED SHOCK, AND CODE 1006 INDICATIVE OF A HIGH VOLTAGE DETECTED ON A LEAD DURING A DEVICE CHARGE. THERE WERE MULTIPLE EPISODES OF NOISE, NON-SUSTAINED VENTRICULAR TACHYCARDIA AND VENTRICULAR TACHYCARDIA, SINCE (B)(6) 2020. THE PATIENT WAS ADMITTED TO THE HOSPITAL TO BE MONITORED CLOSELY. THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ON THE STATUS OF THIS PATIENT HAVE BEEN UNSUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED THAT SURGICAL INTERVENTION OF DEVICE WAS PERFORMED, DEVICE EXPLANTED. IT IS UNKNOWN, BUT SUSPECTED, THAT A NEW DEVICE WAS IMPLANTED. SEVERAL ATTEMPTS TO OBTAIN MODEL/SERIAL OF LEADS HAVE BEEN UNSUCCESSFUL. IT IS UNKNOWN WHERE THE LOCATION OF EXPLANT OCCURRED, AND IF THE DEVICE WILL BE RETURNED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 11741994 ↗
• InjuryApr 27, 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 INFECTION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 11735746 ↗
• InjuryApr 23, 2021Premature 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. THIS DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713404 ↗

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-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-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