RELIANCE 4-FRONT™ 0676Recalls & reported problems

Summary

The FDA's MAUDE database contains 261 adverse event reports that list this exact device (DI 00802526497001), received between May 7, 2019 and Sep 29, 2026 — classified as 209 injuries, 52 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (48 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 261 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 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 implanted and remains in service. Additional information is being requested from the field. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932777 ↗
• InjurySep 11, 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 50732316 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50600119 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50570036 ↗
• MalfunctionAug 18, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) system exhibited high out of range shock impedance measurements above 200 ohms. Technical Services (TS) was consulted, and further in office evaluation was recommended. No adverse patient effects were reported. This system remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306519 ↗
• InjuryAug 16, 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 50264061 ↗
• InjuryAug 12, 2026Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) and right ventricular (RV) lead exhibited oversensing, resulting in pacing inhibition for five seconds. Additionally, inappropriate anti-tachycardia pacing (ATP) therapy and one shock were delivered. It was noted that the company representative planned to follow up with the patient for further investigation. This product remains in service. No adverse patient effects were reported.

  Patient problems: Asystole; Shock from Patient Lead(s)

  MAUDE report 50229852 ↗
• InjuryJul 21, 2026Failure to Read Input Signal; Low impedance; Device Dislodged or Dislocated; Material Integrity Problem; High Capture Threshold

  It was reported that this recently implanted right ventricular (RV) lead exhibited low intrinsic amplitude and an elevated capture threshold. Additionally, the pace and shock impedance measurements were low and within normal limits. Technical Services (TS) was consulted and reviewed data, determining the change in daily measurements indicated a possible lead dislodgement which was confirmed by the local field representative through an x ray. The lead was subsequently explanted and replaced; however, the lead was damaged during the procedure and discarded. No additional adverse effects were reported. This RV lead is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892984 ↗
• InjuryJul 9, 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 SYSTEMIC FUNGAL INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25771478 ↗
• InjuryJul 8, 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25756440 ↗
• InjuryJun 18, 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 POCKET EROSION WITH INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 25549122 ↗
• InjuryJun 18, 2026Insufficient Device Problem Information; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS REVISED DUE TO A PRODUCT PERFORMANCE ANOMALY. THIS RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547857 ↗
• MalfunctionMay 27, 2026Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THIS RECENTLY IMPLANTED RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD HAD A THRESHOLD MEASUREMENT OF 0.4 V AT IMPLANT, AND HAD INCREASED TO 3.5 V THE FOLLOWING DAY. SENSING AND IMPEDANCE MEASUREMENTS APPEARED STABLE, HOWEVER INTERMITTENT LOSS OF CAPTURE (LOC) WAS OBSERVED VIA RIGHT VENTRICULAR AUTOMATIC THRESHOLD (RVAT) TESTING. THE PATIENT HAD TWO CHEST X-RAYS, WHICH DID NOT SHOW CONCLUSIVE EVIDENCE OF LEAD DISLODGEMENT. BASED ON THE CHANGE RV THRESHOLD MEASUREMENTS, LEAD MICRODISLODGEMENT WAS SUSPECTED. 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 25296637 ↗
• InjuryMay 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25177232 ↗
• InjuryMay 8, 2026High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. SUBSEQUENTLY, THE RV LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. OTHER THAN THE INTERVENTION, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129085 ↗
• InjuryMay 7, 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25117978 ↗
• InjuryMay 5, 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 BLOOD INFECTION. THE PATIENT HAD CHRONIC COUGH AND INFECTION WAS FOUND ATTACHED TO A LEAKY VALVE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD REMAINS IN SERVICE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25084102 ↗
• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SYSTEM WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RA AND RV LEADS WAS EXPLANTED DUE TO A NON SPECIFIC REASON BUT THE ICD HAD BEEN IMPLANTED FOR LESS THAN TWO YEARS. ADDITIONAL INFORMATION FROM THE FIELD WAS RECEIVED MENTIONING THE PATIENT WAS ADMITTED TO THE HOSPITAL AND HAD THE WHOLE SYSTEM EXPLANTED SOME DAYS AFTERWARDS DUE TO PATIENT EXHIBITING POCKET INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 25076091 ↗
• InjuryApr 7, 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 24809065 ↗
• MalfunctionApr 7, 2026Mechanical Problem; Positioning Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS NOT SUCCESSFULLY IMPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. A NEW LEAD WITH THE SAME MODEL WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24798869 ↗
• InjuryMar 30, 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24736412 ↗
• InjuryMar 25, 2026Fracture; Insufficient Device Problem Information; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO A PRODUCT PERFORMANCE ISSUE. THIS RV LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED WITH ANOTHER LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694410 ↗
• InjuryMar 20, 2026Signal Artifact/Noise; Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold

  It was reported that one of the leads was disconnected. Patient is scheduled for a procedure. This lead remains in service. No adverse patient effects were reported.Additional information indicated that this right ventricular (RV) lead exhibited high pacing threshold. Also, no pauses were noted due to loss of capture (LOC) or noise. The lead was explanted and replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654093 ↗
• InjuryMar 10, 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24562934 ↗
• InjuryMar 9, 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 24548037 ↗

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-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-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,