ORIGEN™ X4 CRT-D G058Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00802526534515), received between Jul 19, 2019 and Jun 8, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2022Signal Artifact/Noise; High impedance; High Capture Threshold; Noise, Audible; Signal Artifact/Noise; High impedance; High Capture Threshold; Noise, Audible

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE IN THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS. THE DEVICE WAS ALSO NOTED TO EXHIBIT BEEPING TONES. THE LEADS WERE MEASURED WITH THE PACING SYSTEM ANALYZER (PSA) AND THE LV LEAD MEASUREMENTS WERE NOTED TO BE IN RANGE. THE RV LEAD MEASUREMENTS CONTINUED TO BE HIGH AND HIGH THRESHOLD WAS ALSO NOTED. IT WAS MENTIONED THAT THE RV LEAD COULD EXHIBIT A LEAD CONDUCTOR FRACTURE OR AN INSULATION DAMAGE, AND NOISE WAS ALSO OBSERVED IN THIS LEAD. SUBSEQUENTLY, THE CRT-D AND RV LEAD WERE REPLACED AND THE NEW MEASUREMENTS AFTER THE PRODUCTS REPLACEMENT WERE WITHIN ADEQUATE RANGE. THE LV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE CRT-D DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION INDICATES THE CRT-D DEVICE WAS REPLACED TO BE ON THE SAFE SIDE DUE TO THE HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS AND THE BEEPING TONES OBSERVED WERE ALSO CAUSED BY THE HIGH IMPEDANCE MEASUREMENTS. IN ADDITION, THE LV LEAD HIGH OUT OF RANGE IMPEDANCE IS BELIEVED TO BE DUE TO THE STIMULATION BEING SET AGAINST THE RV LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640120 ↗
• InjuryNov 3, 2021Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT PROCEDURE AND UNKNOWN RIGHT VENTRICULAR (RV) LEAD REVISION WITH HIGH IMPEDANCES, THE SETSCREW FOR THE LEFT VENTRICULAR (LV) LEAD WAS UNABLE TO BE UNSCREWED. THE HEADER HAD TO BE CUTOFF AND THE LEFT VENTRICULAR (LV) LEAD HAD TO BE REPLACED. ALL NEW MEASURED VALUES WERE STABLE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749851 ↗
• InjuryMay 5, 2020High impedance; Failure to Sense; Connection Problem; High impedance; Failure to Sense; Connection Problem

  IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT PROCEDURE, THE CHRONIC NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD WAS CONNECTED TO THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BUT NO SENSING WAS OBSERVED AND THE PACING IMPEDANCE MEASUREMENTS WERE HIGH, OUT-OF-RANGE AT GREATER THAN 3,000 OHMS. THE CONNECTIONS WERE CHECKED, AND THE LEAD WAS TESTED AGAIN ON THE PSA, WITH NORMAL IMPEDANCES NOTED. THE LEAD WAS RECONNECTED TO THE DEVICE BUT THE ISSUE DID NOT RESOLVE. A NEW DEVICE OF THE SAME MODEL WAS TRIED AND THE SAME OBSERVATIONS OCCURRED. THEREFORE, THE CHRONIC RV LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A BOSTON SCIENTIFIC RV LEAD. THIS LEAD WAS CONNECTED TO THE SECOND DEVICE AND NORMAL LEAD MEASUREMENTS WERE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE FIRST DEVICE WAS RETURNED AND IS UNDERGOING LABORATORY ANALYSIS.

  Patient problems: No Code Available

  MAUDE report 10023740 ↗
• InjuryJan 30, 2020Data Problem; Data Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS FOUND TO BE IN SAFETY CORE. SURGICAL INTERVENTION WAS PERFORMED AND THE CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9649685 ↗
• MalfunctionJul 19, 2019Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS DEFIBRILLATOR DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP)AND TACHYCARDIA SHOCKS DUE TO A SUSPECTED EPISODE OF ATRIAL DRIVEN ARRHYTHMIA. AFTER THE SHOCKS, PATIENT WAS SEEN BY THE DOCTOR AND HE RESOLVED TO MADE CHANGES TO ZONE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8809095 ↗

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-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-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-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-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-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-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-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.