INOGEN MINI ICD VRRecalls & reported problems across all models

We found 2 models of INOGEN MINI ICD VR by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 203 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2016 and Apr 17, 2025 — classified as 3 deaths, 136 injuries, 64 malfunctions.

The most frequently reported specific device problem is “High impedance” (51 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported INOGEN MINI ICD VR problems

INOGEN MINI ICD VR models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INOGEN™ MINI ICD VR D010

  Implantable cardioverter defibrillator (non-CRT)
  2 deaths131 reports
• INOGEN™ MINI ICD VR D011

  Implantable cardioverter defibrillator (non-CRT)
  1 death72 reports

Recent INOGEN MINI ICD VR adverse event reports

The 15 most recent reports across all models, 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. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856943 ↗
• 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 ↗
• MalfunctionApr 17, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE STATED THAT THEIR REMOTE COMMUNICATOR DISPLAYED A RED CALL DOCTOR ICON, AND THIS COMMUNICATOR WAS NOT CONNECTING. TROUBLESHOOTING WAS PERFORMED AND THE PATIENT WAS GOING TO INVESTIGATE LANDLINE AND TRY TO GET IT WORKING AS IT WAS SUSPECTED THAT THE LANDLINE WAS NOT WORKING. THE PATIENT WAS REFERRED TO THE CLINIC. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19128033 ↗
• 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 ↗
• MalfunctionJan 10, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489040 ↗
• MalfunctionNov 16, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WENT FROM 1.5 YEARS LONGEVITY REMAINING TO SIX MONTHS REMAINING IN A SPAN OF EIGHT MONTHS AND THEN THE DAY AFTER, THIS DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THIS DEVICE WENT BY CHARGE TIME. TS ALSO STATED THAT THIS DEVICE WILL HAVE THE 90-DAY ERI TO END OF LIFE (EOL) WINDOW, BUT IF THERAPY IS NEEDED, CHARGE TIME WILL BE MORE THAN 15 SECONDS. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149324 ↗
• InjuryNov 3, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS DEVICE DELIVERED 5 ROUNDS OF INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND 4 INAPPROPRIATE SHOCKS DUE TO AN EPISODE OF ATRIAL ARRYTHMIA. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 18065697 ↗
• InjuryOct 27, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. UPON REVIEW, IT WAS NOTED THAT THE SHOCK MEASUREMENTS HAVE BEEN HIGH FOR THE PAST YEARS. ALSO, WAS OBSERVED THAT THIS ICD REACHED A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI). A SAVE TO DISK WAS SENT IN FOR ENGINEERING ANALYSIS AND IT WAS CONFIRMED THAT THIS ICD IS DEPLETING NORMALLY AND THE ERI WAS DECLARED DUE TO HIGH VOLTAGES CHARGES IN EXCESS OF 15 SECONDS CONSUMPTION. THIS IS A SECONDARY MECHANISM FOR SETTING ERI AND IS NOT TRACKED BY THE LONGEVITY CALCULATION ALGORITHM. ENGINEERING ANALYSIS CONFIRMS 90-DAY ERI TO EOL (END OF LIFE) IN CASE MORE TIME IS NEEDED. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD WAS SURGICALLY ABANDONED, WHILE THE ICD WAS EXPLANTED. BOTH PRODUCTS WERE SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023281 ↗
• 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 22, 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 A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 17594846 ↗
• 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 ↗
• InjuryMay 31, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD HIGH SHOCK IMPEDANCE ON THE RIGHT VENTRICULAR (RV) CHANNEL. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING ACTIONS, SUCH AS A COMMANDED SHOCK. THE COMMANDED SHOCK WAS CONFIRMED. IT WAS NOTED THAT THE IMPEDANCE VALUE WAS WITHIN RANGE. THE PATIENT WILL CONTINUE TO BE MONITORED. THE DEVICE REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: Electric Shock

  MAUDE report 17032009 ↗
• InjuryApr 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 A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16811840 ↗
• 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 ↗

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