RELIANCE 4-FRONT™ 0662Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00802526592850), received between Jun 20, 2019 and Sep 18, 2026 — classified as 37 injuries, 5 malfunctions.

The most frequently reported specific device problem is “High impedance” (8 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50829859 ↗
• MalfunctionAug 6, 2026Signal Artifact/Noise; Over-Sensing; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158741 ↗
• InjuryJun 12, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD WAS EVALUATED IN THE EMERGENCY ROOM. LEAD CONCERNS WERE DISCUSSED. TECHNICAL SERVICES (TS) CONFIRMED THE LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS. ADDITIONALLY, A SIGNAL ARTIFACT MONITOR (SAM) EPISODE WAS NOTED TO BE RECORDED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THIS LEAD WAS CONNECTED TO RESULTING IN THE RESPIRATORY SENSOR BEING DISABLED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE ICD WAS EXPLANTED DUE TO THERAPY UPGRADE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25494382 ↗
• InjuryMay 19, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE OF WITHIN RANGE PACING IMPEDANCE MEASUREMENTS, MEASURING 1259 OHMS. ADDITIONALLY, THIS LEAD EXHIBITED A GRADUAL INCREASE IN THRESHOLD MEASUREMENTS. AT THIS TIME, THIS RV LEAD REMAINS IN SERVICE, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RV LEAD CONTINUED TO EXHIBIT A GRADUAL INCREASE OF WITHIN RANGE PACING IMPEDANCE MEASUREMENTS, MEASURING 1950 OHMS. IT WAS NOTED THAT THE THRESHOLD MEASUREMENTS WERE STABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222691 ↗
• InjuryApr 27, 2026Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A NONSPECIFIC PRODUCT PERFORMANCE ANOMALY. SUBSEQUENTLY, THIS CRT-D AND RV LEAD WERE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THIS RV LEAD EXHIBITED FRACTURED. THIS PRODUCT IS NOT EXPECTED TO BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009936 ↗
• InjuryApr 14, 2026Adverse 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. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24874573 ↗
• InjuryFeb 19, 2026Failure to Capture; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO PRODUCT PERFORMANCE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24395359 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION AND SEPSIS. REPORTEDLY, THE PATIENT HAD AN INFECTION IN THE BLOODSTREAM THUS AFFECTING THE IMPLANTABLE PRODUCTS AND THEN OPT TO REMOVE THE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS SURGICALLY ABANDONED. DUE TO THE LIMITED INFORMATION RECEIVED, FURTHER FOLLOW-UP TO OBTAIN RELATED DETAILS WAS NOT POSSIBLE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24166456 ↗
• MalfunctionDec 1, 2025Difficult to Insert; Mechanical Problem; Difficult to Remove; Positioning Problem; Difficult to Insert; Mechanical Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS A CASE OF AN ATTEMPTED IMPLANT DUE TO DIFFICULTY IN CROSSING THE TRICUSPID VALVE FOR 20 TO 30 MINUTES WITH STYLET CHANGES AND DIFFICULTY IN PLACING THE TINES IN THE TRABECULA OF THE PATIENT HEART. IN ADDITION, THIS RV LEAD COULD NOT BE ADVANCED NOR RETRACTED COMFORTABLY AND WAS ABLE TO REMOVE WITH AN EXTRA TRACTION. THIS RV LEAD WAS REPLACED WITH A DIFFERENT MODEL, NOT IMPLANTED AND WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680487 ↗
• MalfunctionNov 13, 2025High impedance; High impedance

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED A GRADUAL RISE IN PACE IMPEDANCES TO HIGH OUT-OF-RANGE MEASUREMENTS GREATER THAN 3,000 OHMS. THERE WAS NO EVIDENCE OF INAPPROPRIATE THERAPY OR NOISE. IT WAS NOTED THAT THE PATIENT WAS IN END-STAGE HEART FAILURE, AND THEY ELECTED TO TURN OFF TACHY THERAPY. THIS RV LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539759 ↗
• MalfunctionOct 23, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED CROSS TALK OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) RECOMMENDED REPROGRAMMING OPTIONS OR REPOSITION THE RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368339 ↗
• InjuryAug 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO DISLODGEMENT RESULTING IN UNDERSENSING AND HIGH THRESHOLDS. A NEW RV LEAD WITH A DIFFERENT MODEL WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907413 ↗
• InjuryMay 15, 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 THE SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22032476 ↗
• InjuryApr 23, 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 A POCKET EROSION AND INFECTION. REPORTEDLY, THE PATIENT CAME TO EMERGENCY ROOM AND WAS SEEN BY THE PHYSICIAN HAVING AN INFECTED POCKET CAUSING THE DEVICE TO ERODE THROUGH THE SKIN. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21890669 ↗
• InjuryApr 1, 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 THE SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21749076 ↗
• InjuryDec 30, 2024High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP, THIS RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO EXHIBIT HIGH PACING THRESHOLDS AND HIGH PACING IMPEDANCES WITHIN NORMAL LIMITS (WNL). THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) AND REQUESTED FURTHER REVIEW OF THE STORED DATA. UPON REVIEW, TS DETERMINED THAT THERE WAS A GRADUAL INCREASE IN RV LEAD PACING THRESHOLDS AND PACING IMPEDANCES THAT REMAINED WITHIN NORMAL LIMITS (WNL) OVER THE PAST SIX MONTHS. TS DISCUSSED POSSIBLE CAUSES WITH THE HCP. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THAT A LEAD REVISION PROCEDURE WAS PERFORMED. THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD DUE TO IMPEDANCE ISSUES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044955 ↗
• InjuryNov 29, 2024Adverse 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 DUE TO UNKNOWN ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20813568 ↗
• InjuryNov 4, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO HIGH PACING THRESHOLDS. A NEW RV LEAD WAS SUCCESSFULLY PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599786 ↗
• InjuryOct 15, 2024Adverse 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. THIS RV LEAD WAS EXPLANTED. THE PATIENT WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 20456820 ↗
• InjuryMay 20, 2024Signal Artifact/Noise; Over-Sensing; Low impedance; Signal Artifact/Noise; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED TO THE HOSPITAL DUE TO BEING IN CARDIAC ARREST. THE PATIENT WAS INTUBATED AND WAS PUT ON A VENTILATOR. TECHNICAL SERVICES (TS) REVIEWED THE REPORTS AND FOUND THAT THE LEAD OVERSENSED NOISY SIGNALS IN ONE OF THE VENTRICULAR EPISODES. THERE WERE NO SHOCKS DELIVERED. THE LEAD REMAINS IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Arrest

  MAUDE report 19354842 ↗
• InjuryMay 20, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLD MEASUREMENTS SINCE IMPLANT. THE THRESHOLD MEASUREMENTS WERE FROM 4.5 VOLTS AT 0.4 AND PREVIOUS SESSION WAS AT 6 VOLTS AT 0.4. ADDITIONAL INFORMATION RECEIVED WHICH INDICATED THAT THE PHYSICIAN INFORM THRESHOLD WAS HIGH AT IMPLANT AND THE PRODUCT WAS RETURN BY THE HOSPITAL. THE RV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353613 ↗
• InjuryMay 3, 2024Over-Sensing; Positioning Problem; Over-Sensing; Positioning Problem

  IT WAS REPORTED THAT SHORTLY AFTER IMPLANTATION, THIS RIGHT VENTRICULAR (RV) LEAD WAS OBSERVED TO BE EXHIBITING T-WAVE OVERSENSING. THE PHYSICIAN DETERMINED THE OVERSENSING WAS POSSIBLY DUE TO LEAD PLACEMENT ISSUE. A LEAD REVISION WAS PERFORMED, THE RV LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19241942 ↗
• InjuryMar 28, 2024Adverse 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 SYSTEM REVISION DUE TO INFECTION. ADDITIONAL INFORMATION INDICATED THAT A WOUND VACUUM-ASSISTED CLOSURE (VAC) WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 18992699 ↗
• InjuryFeb 26, 2024Unexpected Therapeutic Results; Under-Sensing; Unexpected Therapeutic Results; Under-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A POSSIBLE DELAY TO MEET THE DETECTION CRITERIA DUE TO INTERMITTENT RIGHT VENTRICULAR (RV) LEAD UNDERSENSING IN A VENTRICULAR FIBRILLATION (VF) EPISODE. THE PATIENT EXPERIENCED A SYNCOPAL EPISODE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED THE ARRHYTHMIA SPONTANEOUSLY TERMINATED. FURTHER EVALUATION BY CARDIOLOGY WAS RECOMMENDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Syncope/Fainting

  MAUDE report 18778633 ↗
• InjuryJan 30, 2024Adverse 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 POCKET INFECTION. REPORTEDLY, PATIENT HAD A SPOT OOZING AROUND THE CORNER OF THE POCKET INCISION. THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 18610229 ↗

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-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,
• 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-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