INOGEN™ MINI ICD DR D013Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00802526533846), received between Apr 22, 2016 and Feb 20, 2023 — classified as 34 injuries, 17 malfunctions.

The most frequently reported specific device problem is “High impedance” (18 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 51 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2023Signal Artifact/Noise; Low impedance; Signal Artifact/Noise; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR CHANNEL AND NOISE ON THE RIGHT ATRIAL CHANNEL. FURTHER REVIEW OF THE DEVICE WAS DISCUSSED. THIS DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404832 ↗
• InjuryNov 16, 2022Premature Discharge of Battery; Pacing Problem; Delayed Charge Time; Battery Problem; Premature Discharge of Battery; Pacing Problem; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY. THREE MONTHS PRIOR TO THE AWARE DATE THE DEVICE SHOWED ELEVEN MONTHS UNTIL EXPLANT, ON THE AWARE DATE THE DEVICE WAS AT BATTERY CAPACITY DEPLETED (BCD). REVIEW OF THE ACTIVITY OF THE DEVICE WAS PERFORMED. AND IT WAS DETERMINED THAT THE CAP REFORM WAS OVER FIFTEEN SECONDS, AND A TOMOGRAPHY SCAN WERE PERFORMED ON THIS PATIENT. THIS INDUCED THE DEPLETION OF THE BATTERY ON THIS DEVICE. THIS DEVICE IS NOT DELIVERING BRADY PACING. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THIS DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15807255 ↗
• InjuryJun 1, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEPLETED QUICKER THAN EXPECTED WITH 11 MONTHS REMAINING LEFT. ALSO, THIS DEVICE BEEPED. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14570334 ↗
• InjuryJul 2, 2021Incorrect, Inadequate or Imprecise Result or Readings; Low impedance; Incorrect, Inadequate or Imprecise Result or Readings; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A SHORT CIRCUIT CONDITION CODE 1004 AFTER DELIVERY OF A SHOCK. THE DEVICE GAVE APPROPRIATE THERAPY IN WHICH BROKE THE PATIENTS ARRHYTHMIA HOWEVER, THE RIGHT VENTRICULAR (RV) SHOCK IMPEDANCE WAS LOW OUT-OF-RANGE (OOR). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED TO REPLACE THE DEVICE AND IT WAS PER PHYSICIAN DISCRETION TO REPLACE THE LEAD. IT WAS RECOMMENDED TO SEND THE DEVICE AND LEAD BACK FOR DEVICE ANALYSIS DETAILS ONCE EXPLANTED. AT THIS TIME, THE ICD AND RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 12112293 ↗
• InjuryMay 6, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACH END OF LIFE (EOL) EARLY. FURTHER, THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11787405 ↗
• InjuryApr 15, 2021Delayed Charge Time; Battery Problem; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED A BATTERY STATUS INDICATOR OF EXPLANT. THE BATTERY STATUS IN SEPTEMBER INDICATED 11 MONTHS REMAINING TO EXPLANT WHILE IN DECEMBER, THE DEVICE TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI). THE EXPLANT INDICATOR WAS FOUND TO BE DUE TO EXTENDED CHARGE TIMES. TECHNICAL SERVICES DISCUSSED AND RECOMMENDED DEVICE REPLACEMENT. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

  Patient problems: Insufficient Information

  MAUDE report 11669410 ↗
• MalfunctionNov 26, 2020High impedance; Over-Sensing; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND A NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE, OVERSENSING, AND INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES. THE NOISE APPEARED TO BE DUE TO RESPIRATORY RATE TREND (RRT) OVERSENSING. THE RA IMPEDANCE MEASUREMENTS HAD INTERMITTENTLY INCREASED IN THE PAST, BUT THERE WERE NO OUT OF RANGE MEASUREMENTS. THE RRT FEATURE WAS BEING PROGRAMMED OFF AND THE PATIENT WOULD CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10908432 ↗
• MalfunctionNov 1, 2020Premature Discharge of Battery; Noise, Audible; Premature Discharge of Battery; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EMITTED BEEPING TONES. THE PATIENT STATED THAT A MONTH AGO, THE DEVICE SHOWED 11 MONTHS REMAINING LONGEVITY. THEN, ELECTIVE REPLACEMENT INDICATOR (ERI) WAS TRIPPED RECENTLY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TOR EACH OUT TO CLINIC TO HAVE ENGINEERS EVALUATE THE REMOTE DATA FOR POTENTIAL PREMATURE BATTERY DEPLETION. AS OF THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10768159 ↗
• InjuryOct 6, 2020Inappropriate/Inadequate Shock/Stimulation; Telemetry Discrepancy; Noise, Audible; Inappropriate/Inadequate Shock/Stimulation; Telemetry Discrepancy; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED DURING A ROUTINE FOLLOW UP. THIS DEVICE WAS ALSO REPORTED TO HAVE EMITTED BEEPING TONES. A CHANGEOUT PROCEDURE WAS SCHEDULED. PRIOR TO CHANGE OUT, THE PATIENT REPORTED RECEIVING NINE SHOCKS DUE TO ATRIAL FIBRILLATION (AF). THIS DEVICE WAS THEN EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock; No Code Available

  MAUDE report 10636807 ↗
• MalfunctionJul 21, 2020Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE HAD REACHED EXPLANT ON (B)(6) OF JUNE WITH LAST CHARGE TIME OF SIXTEEN SECONDS. IN ADDITION, PRIOR TO ONE MONTH THERE WAS ONE YEAR REMAINING. BOSTON SCIENTIFIC TECHNICAL SERVICES DID DISCUSS THAT BATTERY COULD REVERT BACK BUT WOULD ULTIMATELY TRIP AGAIN. AS OF THIS TIME, THIS ICD DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306086 ↗
• InjuryJan 30, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS PATIENT WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE BEEN IN VENTRICULAR TACHYCARDIA (VT) STORM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) NOTED THAT THE DEVICE WAS AT END OF LIFE (EOL) OR LIMITED DEVICE FUNCTIONALITY SCREEN/BEHAVIOR, WHICH DOES INDICATE THAT THE BATTERY WAS EXTREMELY LOW. ADDITIONAL INFORMATION OBTAINED FROM THE FIELD WHICH INDICATED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION (PBD). THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9649690 ↗
• InjuryJan 23, 2020Premature Discharge of Battery; Premature Discharge of Battery

  THIS REPORT IS BEING FILED TO SUBMIT THE ANALYSIS RESULTS.

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

  MAUDE report 9624070 ↗
• InjuryJan 9, 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) DEVICE WAS EXPLANTED AS PART OF A WHOLE SYSTEM EXPLANT DUE TO INFECTION AND SEPSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 9570542 ↗
• InjuryJan 6, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOWED NINE MONTHS REMAINING AND ONE MONTH LATER THE BATTERY STATUS SHOWED THE EXPLANT INDICATOR. ENGINEERING ANALYSIS FOUND THAT ELECTIVE REPLACEMENT INDICATOR (ERI) WAS SET DUE TO TWO CHARGE TIMES OF GREATER THAN 15 SECONDS. FURTHER REVIEW FOUND THAT THE DEVICE IS HIGH RATE ATRIAL SENSING AT AN AVERAGE RATE OF 342 BPM. HIGH RATE ATRIAL SENSING CAN CAUSE AN INCREASE IN POWER CONSUMPTION. THIS INCREASE IN POWER CONSUMPTION MAY HAVE CONTRIBUTED TO THE LONG CAPACITOR CHARGE TIMES AND SHORTER THAN EXPECTED LONGEVITY. IT WAS NOTED THAT THE ICD SHOULD HAVE ENOUGH POWER FOR THE FULL 90 DAY REPLACEMENT PERIOD, HOWEVER BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) NOTED THAT THE CAPACITOR CHARGE TIMES MAY BE GREATER THAN 15 SECONDS. AT THIS TIME THE ICD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 9550888 ↗
• MalfunctionOct 2, 2019Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THAT PATIENT'S COMMUNICATOR DISPLAYED A RED CALL DOCTOR (RCD) ICON, WHICH INDICATES A POTENTIAL ISSUE WITH THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO THEIR FOLLOWING PHYSICIAN. A REMOTE INTERROGATION WAS PERFORMED AND THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT-OF-RANGE (OOR) PACING IMPEDANCES. THE PATIENT'S RA AND RV LEADS WERE NON-BOSTON SCIENTIFIC PRODUCTS. THIS ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9147444 ↗
• MalfunctionSep 20, 2019Telemetry Discrepancy; Inappropriate or Unexpected Reset; Interrogation Problem; Telemetry Discrepancy; Inappropriate or Unexpected Reset; Interrogation Problem

  THIS DEVICE WAS RECENTLY EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND RETURN FOR ANALYSIS.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 9100175 ↗
• InjuryAug 5, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO NON-PRODUCT EXPERIENCE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8860941 ↗
• InjuryJul 23, 2019Migration; Migration

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WAS EXPLANTED DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUE. ADDITIONAL INFORMATION OBTAINED FROM THE FIELD WHICH INDICATED THAT THE DEVICE MIGRATED DOWN INTO THE BREAST TISSUES CAUSING A PAINFUL SENSATION TO THE PATIENT. THE PHYSICIAN PERFORMED A POCKET REVISION AND ELECTED TO REPLACE THE BATTERY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8819664 ↗
• MalfunctionJun 20, 2019High impedance; Over-Sensing; Device Sensing Problem; High impedance; Over-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THE RESPIRATORY RATE SENSOR WAS BEING OVERSENSED ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THIS RESULTED IN INAPPROPRIATE MODE SWITCHING. THE SENSOR WAS PROGRAMMED OFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE. THIS REPORT WILL BE UPDATED, SHOULD ADDITIONAL INFORMATION BE RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8720113 ↗
• InjuryJun 20, 2019High impedance; High impedance

  IT WAS REPORTED THAT PACING IMPEDANCES ON THE NON-BOSTON SCIENTIFIC LEAD(S) CONNECTED TO THIS DEVICE WERE INTERMITTENTLY HIGH OUT OF RANGE. THE PATIENT REPORTEDLY REQUIRED OPEN-HEART SURGERY FOR A NON-DEVICE RELATED REASON AND THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEADS DURING THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8719629 ↗
• MalfunctionApr 11, 2019Defective Device; Defective Device

  THIS REPORT IS BEING FILED TO PROVIDE PRODUCT INVESTIGATION RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8504919 ↗
• InjuryDec 5, 2018Defective Device; Defective Device

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT WORKING. THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8133672 ↗
• MalfunctionNov 28, 2018High impedance; Device Displays Incorrect Message; High impedance; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A VENTRICULAR TACHYCARDIA (VT) STORM. UPON INTERROGATION AN ERROR CODE 1005 WAS DISCOVERED INDICATING THAT THERE WERE SHOCK IMPEDANCES GREATER THAN 145 OHMS. THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD IS A NON-BOSTON SCIENTIFIC PRODUCT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED EVALUATION OF ICD AND RV LEAD SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT HAS HAD SUBSEQUENT SHOCKS WHICH HAVE ALL BEEN APPROPRIATE AND SUCCESSFUL. THE SHOCK IMPEDANCES WERE ALL WITHIN NORMAL LIMITS. THE PATIENT HAS BEEN REFERRED FOR A VT STUDY. THIS PRODUCT REMAINS IN-SERVICE.

  Patient problems: Ventricular Tachycardia

  MAUDE report 8112669 ↗
• InjuryNov 8, 2018Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation; Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR'S (ICD) BATTERY RAPIDLY DEPLETED. THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8053884 ↗
• InjuryJun 19, 2018Failure to Capture; High impedance; Over-Sensing; Pacing Problem; Failure to Capture; High impedance; Over-Sensing; Pacing Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM DISPLAYED A RED ALERT FOR A PACING IMPEDANCE MEASUREMENT GREATER THAN 3000 OHMS ON THE ATRIAL CHANNEL. ADDITIONALLY, OVERSENSING, PACING INHIBITION AND LOSS OF CAPTURE WERE OBSERVED. A REVISION PROCEDURE WAS PERFORMED AND THE ATRIAL LEAD WAS REMOVED FROM SERVICE AND REPLACED. THE ROOT CAUSE OF THE CLINICAL OBSERVATIONS WAS NOT DETERMINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7616849 ↗

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-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