RELIANCE 4-FRONT™ 0636Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00802526496868), received between Apr 21, 2020 and Feb 26, 2026 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (P910073); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Insufficient Device Problem Information; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN REASON. A NEW RV LEAD WAS SUCCESSFULLY PLACED ON THE RV SEPTUM. THIS RV LEAD IS NOT EXPECTED TO BE RETURNED. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE FIELD. NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461306 ↗
• MalfunctionDec 15, 2025Over-Sensing; Off-Label Use; High Capture Threshold; Over-Sensing; Off-Label Use; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLDS. TECHNICAL SERVICES (TS) REVIEWED ELECTROGRAM (EGM) DATA FROM PAST EVENTS AND OBSERVED DISTINCT MORPHOLOGIES ON THE RATE SENSE CHANNELS, DEPENDING ON WHETHER THE LEFT VENTRICULAR (LV) OR RV WAS ACTIVE. THE FACILITY PLANS TO BRING THE PATIENT IN FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED FOR ASSISTANCE WITH PROGRAMMING THIS LV LEAD INTO MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE. TECHNICAL SERVICES (TS) INFORMED THIS IS A NON-CONDITIONAL SYSTEM AND PROGRAMMED THE DEVICE. AFTER THE MRI WAS PERFORMED, THIS SYSTEM WAS REMOVED FROM THE MRI PROTECTION MODE, IT WAS CONFIRMED THAT ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS AND WAS FUNCTIONING AS INTENDED. THIS RV LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE EXHIBITED T-WAVE OVERSENSING. TS PROVIDED REPROGRAMMING TO AVOID THE ISSUE IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804538 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22895092 ↗
• MalfunctionNov 5, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS ATTEMPTED DUE TO OVERSENSING. A NEW LEAD WITH SAME MODEL WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614133 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS TACHY LEAD WAS SURGICALLY EXPLANTED DUE TO OTHER OR NON PRODUCT EXPERIENCED. THIS TACHY LEAD WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575237 ↗
• MalfunctionNov 7, 2023Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD SHOWED LOSS OF CAPTURE (LOC) AT FULL OUTPUT. HEALTH CARE PROFESSIONAL (HCP) WAS GOING TO REVIEW THE CASE WITH THE CARDIOLOGIST. THE RV LEAD REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18081599 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO SYSTEMIC INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 17693827 ↗
• InjuryAug 25, 2023Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLD. THIS LEAD WAS SURGICALLY ABANDONED, AND A NEW LEAD WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE WAS OBTAINED WHICH INDICATED THAT THE SUSPECTED CAUSE OF HIGH PACING THRESHOLD WAS MICRO DISLODGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627735 ↗
• InjuryApr 14, 2023Signal Artifact/Noise; Failure to Convert Rhythm; Under-Sensing; Signal Artifact/Noise; Failure to Convert Rhythm; Under-Sensing

  IT WAS REPORTED THAT PHYSIOLOGIC NOISE COMING FOR THIS PATIENT WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INDUCED THE PATIENT INTO A VENTRICULAR TACHYCARDIA EPISODE THAT EVOLVED INTO VENTRICULAR FIBRILLATION. FURTHERMORE, UNDERSENSING WAS OBSERVED ON THIS RIGHT VENTRICULAR LEAD, EVEN THOUGH, THE DEVICE WAS STILL ABLE TO DELIVER ANTI-TACHYCARDIA PACING (ATP) THERAPY ON THE PATIENT, HOWEVER THEY WERE NOT SUCCESSFUL. EVENTUALLY THE EPISODE ENDED DUE TO EXTERNAL SHOCK PROVIDED TO THE PATIENT. FURTHER EVALUATION OF THE PATIENT WAS DISCUSSED. THIS LEAD REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock; Ventricular Fibrillation

  MAUDE report 16744164 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16121284 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED LESS THAN ONE MONTH AFTER IMPLANT DUE TO AN UNKNOWN ISSUE. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15251312 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INFECTION AND WAS PART OF THE SYSTEM REVISION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 14215571 ↗
• InjuryJul 23, 2021Defective Device; Device Dislodged or Dislocated; Defective Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD APPEARED TO BE IN THE RIGHT ATRIAL (RA) BASED ON X-RAY. FURTHER, THIS LEAD WAS EXPLANTED DUE TO LOOSE CONNECTION AND DISLODGEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218741 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD A POCKET INFECTION. REPORTEDLY, THE PATIENT WAS HOSPITALIZED, AND BLOOD CULTURE CAME BACK POSITIVE FOR BURKHOLDERIA CEPACIA BACTEREMIA. THE PATIENT RETURNED TO THE HOSPITAL AS THE INFECTION STARTED TO GET WORSE WHERE COMPLAINTS OF REDNESS AND PAIN ON THE LEFT SIDE OF THE CHEST OCCURRED. THE POCKET WAS ALSO INFLAMED. THE PHYSICIAN OPTED TO DO A SYSTEM EXTRACTION. UPON OPENING THE POCKET, A PURULENT MATERIAL WAS IDENTIFIED COMING FROM THE DEVICE POCKET. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV WAS EXPLANTED.

  Patient problems: Bacterial Infection; Inflammation; Pain; Purulent Discharge

  MAUDE report 9982097 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P910073. One submission often covers many models, so check the product and lot details in each record.

• Z-2325-2025 · Jul 24, 2025 · Open, Classified
  ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o18
• Z-2326-2025 · Jul 24, 2025 · Open, Classified
  ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
• Z-2327-2025 · Jul 24, 2025 · Open, Classified
  RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692,