INOGEN™ CRT-D G141Recalls & reported problems

Summary

The FDA's MAUDE database contains 415 adverse event reports that list this exact device (DI 00802526534553), received between Apr 22, 2016 and Sep 23, 2026 — classified as 1 death, 220 injuries, 194 malfunctions.

The most frequently reported specific device problem is “High impedance” (169 reports).

19 other recalls cover devices cleared under the same FDA submission (P010012); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 415 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of a system revision due to infection. There were no additional adverse patient effects reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50873067 ↗
• InjuryAug 19, 2026Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was found to be operating in Safety Mode. It was noted that Safety Mode was identified only after the device had been explanted and interrogated on the procedure table. Prior to explant, the local company representative had programmed tachycardia therapy off. This product has not been returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326202 ↗
• MalfunctionMay 17, 2026Interrogation Problem

  IT WAS REPORTED THAT DURING AN IN-OFFICE VISIT THERE WAS DIFFICULTY INTERROGATING THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING EFFORTS AND PERFORMED. HOWEVER, THE CRT-D WAS UNABLE TO BE INTERROGATED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196742 ↗
• InjuryMay 15, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS PATIENT WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WANTED TO KNOW IF THERE WAS ANY ACTIVITY ON THE DEVICE BECAUSE THEY EXPERIENCED A SYNCOPAL EPISODE AFTER PULLING OVER ON THE SIDE OF THE ROAD WHILE DRIVING. IT WAS NOTED THAT THE PATIENT HAD A RECENT MEDICATION SWITCH. TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO THEIR PHYSICIAN. THIS CRT-D REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 25186866 ↗
• InjuryMay 12, 2026Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POTENTIALLY ACCELERATED THE PATIENT INTO VENTRICULAR TACHYCARDIA (VT). THE PATIENT REPORTED HAVING TUNNEL VISION WHILE SITTING DOWN. THE DEVICE DELIVERED THERAPY THAT CONVERTED THE RHYTHM AND THE PATIENT WAS TOLD TO VISIT THE EMERGENCY ROOM (ER). TECHNICAL SERVICES (TS) REVIEWED THE EVENT AND RECOMMENDED POTENTIAL PROGRAMMING CHANGES FOR THE DEVICE. THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Presyncope; Tachycardia

  MAUDE report 25154979 ↗
• MalfunctionMay 5, 2026Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SUSPECTED TO EXHIBIT LOSS OF CAPTURE (LOC) AND LEFT VENTRICULAR (LV) PACING DELAY. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON REVIEW OF THE AVAILABLE INFORMATION TS WAS NOT ABLE TO DETERMINE IF LOC WAS PRESENT. FURTHER IN CLINIC EVALUATION WAS RECOMMENDED. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088186 ↗
• MalfunctionApr 6, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED AN INAPPROPRIATE SHOCK. THE PATIENT WENT INTO A VENTRICULAR TACHYCARDIA (VT) EPISODE BUT THEIR RHYTHM BROKE, AND THE CHARGE DIVERTED. THE PATIENT WENT INTO A VT EPISODE AGAIN, AND THE RHYTHM BROKE AGAIN BEFORE THE CHARGE COMPLETED. THE PATIENT WENT INTO A VT EPISODE FOR A THIRD TIME, BUT THEIR RHYTHM BROKE AGAIN; HOWEVER, A SHOCK WAS DELIVERED. THE HEALTH CARE PROFESSIONAL (HCP) QUESTIONED WHY THE PATIENT GOT SHOCKED. TECHNICAL SERVICES (TS) EXPLAINED THE DEVICE CANNOT HAVE TWO DIVERTS IN A ROW AND RECOMMENDED REPROGRAMMING OPTIONS. THIS DEVICE WAS REPROGRAMMED AND IT WAS NOTED MEDICATION WOULD BE ADDRESSED WITH THE PATIENT. THIS CRT-D REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24794308 ↗
• MalfunctionMar 24, 2026Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT DURING VENTRICULAR TACHYCARDIA (VT) ABLATION THE PATIENT EXPERIENCED A TRANSIENT LOSS OF CAPTURE WHILE PROGRAMMED IN DOO MODE. SWITCHING TO VOO IMPROVED CAPTURE, AND FUNCTION WAS NORMAL BEFORE AND AFTER DELIVERY OF RADIOFREQUENCY ENERGY. TECHNICAL SERVICES DISCUSSED THE DEFIB DETECT CIRCUITRY, NOTING ITS ROLE IN TRUNCATING PACING DURING ABLATION. A REPRESENTATIVE WAS PRESENT AT BEDSIDE PERFORMING DEVICE EVALUATION, AND THE PATIENT IS NOT PACEMAKER DEPENDENT. CURRENTLY, THIS PRODUCT REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678912 ↗
• MalfunctionMar 4, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS, MEASURING GREATER THAN 125 OHMS. TECHNICAL SERVICES (TS) RECOMMENDED MONITORING THE IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS CRT-D WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION (NBD). NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512898 ↗
• MalfunctionJan 9, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED INAPPROPRIATE MODE SWITCHES TO ATRIAL TACHY RESPONSE (ATR) DUE TO OVERSENSING OF NOISY SIGNALS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24026685 ↗
• InjuryDec 9, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Convert Rhythm; High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Convert Rhythm

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED A CODE 1005 INDICATIVE OF AN OPEN CIRCUIT CONDITION. THE PATIENT EXPERIENCED TWO EPISODES OF VENTRICULAR FIBRILLATION (VF). ON BOTH EPISODES, THE PATIENT RECEIVED SEVEN SHOCKS WHICH DID NOT CONVERT AND MANAGED TO CONVERT ON THE EIGHTH SHOCK. THEREFORE, THE PATIENT WAS IN VF FOR APPROXIMATELY THREE MINUTES. ADDITIONALLY, THE SHOCK IMPEDANCE MEASUREMENTS WERE NOTED TO BE HIGH WITHIN RANGE INCREASING GRADUALLY IN THE RIGHT VENTRICULAR (RV) CHANNEL. THIS CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 23758684 ↗
• InjuryDec 3, 2025Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED AN ALERT FOR HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ABOVE 200 OHMS ON THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED, AND UPON REVIEW IT WAS NOTED THAT THERE WAS NOISE ON THE RV LEAD AND NON-BOSTON SCIENTIFIC LEFT VENTRICULAR (LV) LEAD, CAUSING OVERSENSING AND PACING INHIBITION ON THE LV CHANNEL. POSSIBLE LOSS OF CAPTURE (LOC) AND A SUSPECTED FRACTURE WAS ALSO NOTED ON THE RV CHANNEL. TS ADVISED ON FURTHER IN OFFICE EVALUATION OF THE SYSTEM. AS A RESULT, THIS CRT-D SYSTEM WAS REPROGRAMMED WITH TACHY THERAPIES OFF AND TO EXCLUDE THE RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711067 ↗
• MalfunctionDec 1, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED SIGNAL ARTIFACT MONITOR EPISODES AND EXHIBITED OVERSENSING DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) WHILE USING A MAGNET DURING SURGERY. TECHNICAL SERVICES WAS CONSULTED AND CONFIRMED THE EPISODES DURING A POST-SURGERY CHECK AND NOTED CHRONIC ATRIAL FIBRILLATION APPEARED ON THE PRESENTING ELECTROGRAM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679772 ↗
• MalfunctionNov 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) STATED THAT THEIR REMOTE COMMUNICATOR DISPLAYED A RED CALL DOCTOR ICON. SUBSEQUENTLY, TROUBLESHOOTING WAS PERFORMED, AND THE COMMUNICATOR WAS POWER CYCLED, AND A SUCCESSFUL PATIENT-INITIATED INTERROGATION WAS SENT. THE PATIENT WAS REFERRED TO CONTACT THEIR CLINIC REGARDING THE RED CALL DOCTOR ICON. AT THIS TIME, THIS CRT-D REMAINS IN SERVICE AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23515160 ↗
• MalfunctionNov 5, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THIS PATIENT WAS EXPERIENCING BRADYCARDIA AND IS CONCERNED ABOUT THE IMPLANTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE PHYSICIAN WILL REVIEW ALL INFORMATION. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 23480281 ↗
• InjuryOct 31, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED SUPRAVENTRICULAR TACHYCARDIA (SVT) WHICH RESULTED IN THE INAPPROPRIATE DELIVERY OF ANTI-TACHYCARDIA PACING (ATP), AND SEVEN SHOCKS. THE THERAPY WAS SUBSEQUENTLY EXHAUSTED. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED PROGRAMING OPTIONS. THIS DEVICE REMAINS IN SERVICE AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23437175 ↗
• MalfunctionOct 30, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR REVIEW OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTING ELECTROGRAM (EGM) DUE TO CONCERNS OF LEFT VENTRICULAR (LV) LEAD LOSS OF CAPTURE (LOC). IT WAS NOTED THAT THE LV LEAD IS LOCATED IN THE LEFT BUNDLE BRANCH BLOCK (LBBB) POSITION AND IS A NON-BOSTON SCIENTIFIC LEAD. UPON REVIEW, THE PRESENTING EGM SHOWED INTERMITTENT LOC ON THE LV LEAD. TS RECOMMENDED FOR AN IN PERSON EVALUATION OF THRESHOLDS BE PERFORMED. AT THIS TIME, THIS CRT-D AND NON-BOSTON SCIENTIFIC LV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430802 ↗
• MalfunctionOct 27, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. PROGRAMMING EFFORTS WERE PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23392400 ↗
• InjuryOct 24, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED 16 BURSTS OF ANTI-TACHYCARDIA PACING (ATP) AND THREE SHOCKS AS INAPPROPRIATE THERAPY DUE TO OVERSENSING OF NOISY SIGNALS. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380947 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION. SUBSEQUENTLY, A TEMPORARY WIRE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 23295106 ↗
• MalfunctionSep 18, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) STATED OF BEING ADVISED TO VISIT THE NEAREST EMERGENCY ROOM DUE TO A LOW BATTERY READING ON DEVICE. TECHNICAL SERVICES (TS) CHECKED AND FOUND OUT THAT THERE WERE NO PREVIOUS CALL LOGS AVAILABLE, AND THIS DEVICE WAS NOT ENROLLED IN LATITUDE SYSTEM. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND TS SUGGESTED TO INTERROGATE THE DEVICE OR IDENTIFY THE SOURCE OF THE CALL TO THE PATIENT FOR FURTHER CLARIFICATION. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088869 ↗
• InjuryAug 19, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A SUSPECTED LOSS OF CAPTURE (LOC) FOR ITS RIGHT ATRIAL (RA) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA. THE PATIENT WILL CONTINUE TO BE MONITORED AND THE RA LEAD WILL BE EVALUATED AT THE CRT-D CHANGEOUT. THERE IS NO INDICATION A CHANGEOUT OR REVISION HAS BEEN SCHEDULED AT THIS TIME. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT A LATER DATE, THIS CRT-D WAS RECEIVED FOR ANALYSIS, INDICATING AN EXPLANT PROCEDURE HAS TAKEN PLACE BUT NO INFORMATION REGARDING THE PROCEDURE HAS BEEN RECEIVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE HAS BEEN ANALYZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22844234 ↗
• InjuryAug 18, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INAPPROPRIATE BV TRIGGER PACING WHICH DEGRADED TO FASTER VENTRICULAR TACHYCARDIA (VT) WITH THERAPY. THERAPY WAS APPROPRIATE. TECHNICAL SERVICES (TS) RECOMMENDED ADJUSTING OR MEDICAL MANAGEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia

  MAUDE report 22835415 ↗
• MalfunctionAug 13, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED LEFT VENTRICULAR (LV) LEAD HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS. LEAD TESTING WAS PERFORMED AND IT SHOWED NO SIGNS OF A LEAD PROBLEM. TECHNICAL SERVICES (TS) WAS CONSULTED, DISCUSSED POSSIBLE SPRING CONTACT ISSUE AND NOTED IMPEDANCES HAD BEEN FLUCTUATING FOR A WHILE. TS SUGGESTED REPROGRAMMING OPTIONS. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794376 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) STATED THAT THIS DEVICE HAD BEEN ACCIDENTALLY BUMPED, LEADING TO PUFFINESS AT THE IMPLANT SITE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. AS OF THIS TIME, THE CRT-D REMAINS IN SERVICE.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22744052 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010012. One submission often covers many models, so check the product and lot details in each record.

• Z-1671-2022 · 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-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, 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-1556-2010 · Mar 15, 2010 · Terminated
  Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillat
• Z-0609-2010 · Dec 1, 2009 · Terminated
  Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107,
• Z-1055-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are design
• Z-1053-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventric
• Z-1052-2007 · Mar 23, 2007 · Terminated
  VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. P
• Z-1054-2007 · Mar 23, 2007 · Terminated
  VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 U
• Z-1047-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North,
• Z-1049-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
• Z-0047-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872.
• Z-1288-06 · May 15, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Ave
• Z-0825-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100

…and 4 more.