RELIANCE 4-FRONT™ 0663Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00802526592805), received between Oct 1, 2020 and Aug 20, 2026 — classified as 16 injuries, 12 malfunctions.

The most frequently reported specific device problem is “High impedance” (12 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026High impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360108 ↗
• InjuryAug 12, 2026Device Sensing Problem

  It was reported that this right ventricular (RV) lead was surgically explanted and replaced due to poor sensing. The patient was stable with no additional adverse effects. This RV lead is expected to be returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225894 ↗
• InjuryJul 2, 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 WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25694616 ↗
• MalfunctionApr 28, 2026High impedance

  IT WAS REPORTED THAT COMMUNICATOR FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A RED CALL DOCTOR ICON DUE TO RIGHT VENTRICULAR (RV) LEAD SHOCK IMPEDANCES BEING OUT OF RANGE. THE IMPEDANCES WERE REVIEWED AND FOUND IT WAS A GRADUAL RISE. THIS RV LEAD AND ICD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019574 ↗
• InjuryJan 28, 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 24204646 ↗
• InjuryDec 2, 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 WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23695169 ↗
• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23674070 ↗
• InjuryNov 6, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED ASSISTANCE WITH PROGRAMMING MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. TECHNICAL SERVICES (TS) REVIEWED AND NOTED THERE WAS LOSS OF CAPTURE (LOC) AND HIGH CAPTURE THRESHOLDS ON THE RIGHT VENTRICULAR (RV) LEAD. SUBSEQUENTLY, THIS ICD AND RV LEAD WERE EXPLANTED AND REPLACED. 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 23490987 ↗
• MalfunctionOct 24, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN OUT OF RANGE GRADUAL INCREASE IN SHOCK LEAD IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED TROUBLESHOOTING OPTIONS. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376652 ↗
• InjurySep 5, 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 22979117 ↗
• InjuryAug 6, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING PACING IMPEDANCE OUT OF RANGE. THE MD INDUCED VENTRICULAR FIBRILLATION (VF) WHICH THE DEVICE CONVERTED. NO NOISE OR SENSING ISSUES WERE SEEING, BUT THRESHOLD WAS SLIGHTLY HIGHER. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 22731904 ↗
• MalfunctionApr 23, 2025High impedance; Pacing Problem; High Capture Threshold; High impedance; Pacing Problem; High Capture Threshold

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED A GRADUAL RISE IN PACE IMPEDANCE MEASUREMENTS FROM MID-400 OHMS RANGE TO GREATER THAN 2,000 OHMS SINCE (B)(6) 2024. RV THRESHOLD HAD ALSO INCREASED FROM LESS THAN 1V TO APPROXIMATELY 1.5V. THERE WAS NO EVIDENCE OF NOISE IN STORED EPISODES. SENSING WAS STABLE, HOWEVER THERE WAS NO PACING AT ALL. WHEN ASKED ABOUT CHANGES IN MEDICAL HISTORY AROUND LATE (B)(6) 2024, AND IT WAS NOTED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR CORONARY ARTERY DISEASE. TECHNICAL SERVICEES (TS) DISCUSSED THAT CHANGES IN PATIENT CONDITION CAN IMPACT LEAD MEASUREMENTS AND MAY BE INDICATIVE OF LEAD CALCIFICATION. TS ALSO REVIEWED TROUBLESHOOTING/PROGRAMMING CONSIDERATIONS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893834 ↗
• InjuryApr 9, 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 21807294 ↗
• MalfunctionOct 17, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL RISE IN PACE IMPEDANCE MEASUREMENTS FROM THE MID-500 OHMS RANGES TO GREATER THAN 2,000 OHMS, WITH A RECENT MEASUREMENT OF 2,244 OHMS. IT WAS NOTED THAT THIS CHANGE WAS LIKELY INDICATIVE OF A PHYSIOLOGIC CAUSE. SHOCK IMPEDANCE MEASUREMENTS WERE STABLE IN THE 70 OHMS RANGE. R-WAVE AMPLITUDE WAS GREATER THAN 14 MV AND AND THE THRESHOLD WAS 0.8V @ 0.4 MS. HEALTH CARE PROFESSIONAL (HCP) PERFORMED LEAD TESTING WITH ISOMETRICS, BUT THERE WAS NO EVIDENCE OF NOISE OR HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20477352 ↗
• MalfunctionMay 17, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE PACING IMPEDANCE MEASUREMENTS, MEASURING AT 2651 OHMS. UPON REVIEW, THERE WAS NO NOISE STORED AND THERE WAS A GRADUAL RISE IN THE IMPEDANCES. TECHNICAL SERVICES (TS) STATED THAT AMPLITUDE AND THRESHOLD MEASUREMENTS WERE STABLE. THIS RV LEAD CURRENTLY REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340513 ↗
• MalfunctionDec 11, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS MEASURING, 131 OHMS. TECHNICAL SERVICES (TS) REVIEWED THE PRESENTING ELECTROGRAM (EGM) AND FOUND THERE WERE NO OBSERVATIONS OF NOISE. TS INFORMED THE HEALTH CARE PROFESSIONAL (HCP) THAT THE SINGLE COIL LEADS WILL RUN HIGHER WHICH IS BY DESIGN AND PROVIDED TROUBLESHOOTING OPTIONS. AT THIS TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18303566 ↗
• InjuryNov 28, 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 18220392 ↗
• InjuryNov 7, 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 CONSTANT IRRITATION AT THE DEVICE SITE. THE PATIENT ALSO REPORTED THAT WIRES WERE VISIBLE UNDER THE SKIN WHEN PRESSING DOWN AT THE TOP LEFT CORNER. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: Pocket Erosion; Skin Inflammation/ Irritation; Swelling/ Edema; Unspecified Infection

  MAUDE report 18088588 ↗
• MalfunctionSep 25, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS SYSTEM WITH A TACHY DEVICE AND RIGHT VENTRICULAR (RV) LEAD SHOWED HIGH, OUT OF RANGE SHOCK IMPEDANCE. THE SYSTEM HAS BEEN RECENTLY IMPLANTED. ISOMETRICS AND POCKET MANIPULATIONS DID SHOW HIGH IMPEDANCES. AN X RAY ANALYSIS WAS RECOMMENDED. THE RV LEAD AND TACHY DEVICE REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17813077 ↗
• InjuryJul 5, 2023Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED, WHICH WAS CONFIRMED THROUGH CHEST X-RAY, AND EXHIBITED LOSS OF CAPTURE (LOC) AND HIGH IMPEDANCE MEASUREMENTS. THIS LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17256848 ↗
• MalfunctionMar 29, 2023Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED NOISE AND OVERSENSING ON THIS RIGHT VENTRICULAR (RV) LEAD THAT RESULTED IN INTERMITTENT PACING INHIBITION OF LESS THAN TWO SECONDS. THIS PATIENT WAS DEPENDENT ON RV PACING. FURTHER INVESTIGATION WAS DISCUSSED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: Asystole

  MAUDE report 16639948 ↗
• MalfunctionNov 17, 2022Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNDERSENSING ON THE VENTRICULAR CHANNEL. THIS RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND MULTIPLE ELECTRIC SHOCKS DUE TO AN ATRIAL DRIVEN ARRHYTHMIA. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED PROGRAMMING OPTIONS AS WELL AS MEDICATION OPTIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE SYSTEM REMAINS IN SERVICE.

  Patient problems: Electric Shock

  MAUDE report 15814679 ↗
• InjuryOct 6, 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 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 15550935 ↗
• MalfunctionMay 27, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REACHED UP TO TECHNICAL SERVICES (TS) REGARDING CONCERNS ABOUT THE OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A RED CALL DOCTOR ICON DUE TO THE RIGHT VENTRICULAR (RV) LEAD EXHIBITING OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS. TROUBLESHOOTING OPTIONS WERE DISCUSSED AND THE HCP IS GOING TO DISCUSS THEM WITH THE PHYSICIAN. CURRENTLY, THE RV LEAD REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522922 ↗
• MalfunctionMar 7, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF 139 OHMS. THE SHOCK IMPEDANCE HAD BEEN IN THE 90 OHM RANGE PREVIOUS TO THE OUT OF RANGE MEASUREMENT. THE RV PACE IMPEDANCE WAS ALSO NOTED TO HAVE EXHIBITED A CHANGE ON THE SAME DATE, GOING FROM 483 OHMS TO 602 OHMS. THIS IS STILL WITHIN NORMAL SPECIFICATION LIMITS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED WITH THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT WITH ONLY ONE OUT OF RANGE MEASUREMENT, THEY CAN CONSIDER CONTINUED MONITORING FOR NOW. TS NOTED THAT THIS IS A SINGLE COIL LEAD, SO THEY ARE NOT ABLE TO CHECK OTHER VECTORS. THE REPRESENTATIVE INDICATED THAT THEY UNDERSTAND AND AGREE. THE RV LEAD REMAINS IN-SERVICE. NO PATIENT SYMPTOMS OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13684740 ↗

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-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,
• 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