RELIANCE 4-FRONT™ 0665Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00802526496967), received between Apr 21, 2020 and Oct 28, 2025 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED GRADUAL RISING PACING IMPEDANCES OUT OF RANGE. TECHNICAL SERVICES (TS) REVIEWED AND NOTED IT WAS THE PHYSICIAN'S DISCRETION FOR WHEN TO REPLACE THIS LEAD. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD. THIS LEAD WAS 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 23401017 ↗
• MalfunctionAug 20, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD DELIVERED AN ANTI-TACHYCARDIA PACING (ATP) THERAPY, HEALTH CARE PROFESSIONAL (HCP) BELIEVED IT WAS DUE TO T-WAVE OVERSENSING (TWOS). THE PATIENT HAS A LEFT VENTRICULAR ASSIST DEVICE (LVAD). TECHNICAL SERVICES (TS) REVIEWED THE EPISODE AND DETERMINED THAT THE THERAPY DID NOT APPEAR TO BE CAUSED BY TWOS. INSTEAD, THE INAPPROPRIATE ATP MAY HAVE RESULTED FROM OVERSENSING OF THE LVAD PUMP SIGNALS, WITH NO EVIDENCE OF A TRUE VENTRICULAR ARRHYTHMIA. TS DISCUSSED THE POSSIBILITY THAT THE OVERSENSING COULD BE POSITIONAL. HEALTH CARE PROFESSIONAL (HCP) WILL FOLLOW UP WITH PHYSICIAN. THE LEAD REMAINS IN SERVICE, AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22852332 ↗
• InjuryApr 21, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE (LOC). AS A RESULT, TACHY THERAPY FOR THE RV WAS TURNED OFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878149 ↗
• InjuryApr 25, 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.

  Patient problems: Unspecified Infection

  MAUDE report 19181439 ↗
• InjuryFeb 20, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO HIGH CAPTURE THRESHOLD MEASUREMENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18742352 ↗
• InjuryFeb 12, 2024Adverse 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 HAD AN INFECTION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD REMAINS IN SERVICE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 18684354 ↗
• InjuryJan 17, 2024Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS ALONG WITH LOSS OF CAPTURE (LOC) ON THE PRESENTING ELECTROGRAM (EGM). THIS PATIENT WAS NOT PACEMAKER DEPENDENT AT THAT TIME. TECHNICAL SERVICES (TS) RECOMMENDED TO CONSIDER A CHEST X RAY. THE X RAY WAS OBTAINED WHICH DID NOT SHOW A RV LEAD ISSUE RATHER A LEFT VENTRICULAR (LV) LEAD THAT WAS UNDER INSERTED. IT WAS NOTED THAT THIS PATIENT HAS COMORBIDITIES SPECIFICALLY ESOPHAGEAL CANCER AND HIS LIFE EXPECTANCY MAYBE NOT EXCEED THE DEVICE LONGEVITY. THE FIELD REPRESENTATIVE WILL LEAVE IT UP TO THE PHYSICIAN AS TO THE FUTURE PLAN FOR THIS PATIENT REGARDING POSSIBLE PROGRAMMING CHANGES OR SURGICAL INTERVENTION. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526218 ↗
• InjuryDec 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 WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 16048713 ↗
• InjuryDec 13, 2022Device Dislodged or Dislocated; Impedance Problem; High Capture Threshold; Device Dislodged or Dislocated; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED ONE DAY AFTER THE IMPLANT PROCEDURE. THE DISLODGEMENT WAS DISCOVERED DUE IT PRESENTING RISING THRESHOLD MEASUREMENTS AND IMPEDANCE CHANGES. THE LEAD WAS REVISED AND REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15968553 ↗
• InjurySep 6, 2022Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS PATIENT UNDERWENT A PLANNED SYSTEM REPLACEMENT PROCEDURE TO UPGRADE THERAPY FROM A PACEMAKER SYSTEM TO AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED OUT OF THE SURGICAL SUITE AND PUT ON A MONITOR. THE NURSES MONITORING THE PATIENT CONTACTED THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE WHO ATTENDED THE SURGICAL PROCEDURE APPROXIMATELY ONE HOUR LATER INDICATING THE PATIENT WAS EXHIBITING PAUSES IN RHYTHM AND SOME ASYSTOLE AS OBSERVED ON THE MONITOR. THE PATIENT WAS NOTED TO BE PACE THERAPY DEPENDENT. THE PATIENT ALSO DESCRIBED A SENSATION OF WHAT FELT LIKE ELECTRICITY RUNNING DOWN THEIR ARM. THE PATIENT WAS PROVIDED EXTERNAL PACING THERAPY AND A CHEST TUBE WAS PLACED DUE TO PNEUMOTHORAX. WHEN THE REPRESENTATIVE ARRIVED BACK AT THE HOSPITAL, THIS NEWLY IMPLANTED RIGHT VENTRICULAR (RV) LEAD WAS REPROGRAMMED TO MAXIMUM PACING OUTPUT AND CONSISTENT CAPTURE WAS OBSERVED. THE PHYSICIAN ELECTED TO REPOSITION THE NEW RV LEAD AND CONNECTED A PACING SYSTEM ANALYZER (PSA) TO THE PREVIOUS RV LEAD THAT HAD BEEN SURGICALLY ABANDONED IN ORDER TO PROVIDE PACING THERAPY DURING THE SURGICAL PROCEDURE. THE NEW RV LEAD WA

  Patient problems: Asystole; Discomfort; Pneumothorax

  MAUDE report 15365716 ↗
• MalfunctionJul 4, 2022Device Sensing Problem; Device Dislodged or Dislocated; High Capture Threshold; Device Sensing Problem; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD SHOWED HIGH THRESHOLDS WHEN PATIENT IS LAYING DOWN. MOREOVER, NOISE WAS NOTED AND BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INDICATED THAT THE LEAD APPEARED TO BE DISLODGED. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911429 ↗
• InjuryApr 28, 2022Defective Device; Device Dislodged or Dislocated; High Capture Threshold; Defective Device; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLDS. DURING A SCHEDULED CHECK-UP, THE PATIENT'S HEART RATE DROPPED, AND DEVICE OUTPUT WAS INCREASED TO ENSURE CAPTURE. MOREOVER, A CHEST X-RAY WAS DONE, AND DISLODGEMENT WAS CONFIRMED. SUBSEQUENTLY, THE PATIENT UNDERWENT A POCKET REVISION, AND THE PHYSICIAN TRIED TO MOVE THE LEAD BACK IN PLACE BUT WAS UNSUCCESSFUL. THIS RV LEAD WAS EXPLANTED, AND A NEW LEAD WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246515 ↗
• InjuryJan 27, 2022Failure to Capture; Device Sensing Problem; High Capture Threshold; Migration; Failure to Capture; Device Sensing Problem; High Capture Threshold; Migration

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING LOSS OF CAPTURE, LOW SENSING AND HIGH PACING THRESHOLDS DUE TO A LEAD MIGRATION. AS A RESULT THIS LEAD WAS REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13377254 ↗
• InjuryOct 13, 2021Adverse 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 WITH SEPSIS. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 12625965 ↗
• InjuryMay 4, 2021High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLD MEASUREMENTS. A REVISION WAS PERFORMED TO REPOSITION THE LEAD. HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE LEAD FURTHER AS THE POCKET WAS TIGHT. THE PLAN WAS TO SEND THE PATIENT FOR A TOTAL LEAD EXTRACTION TWO TO THREE WEEKS FROM THIS TIME. ADDITIONAL INFORMATION RECEIVED WHICH INDICATED THAT THIS LEAD WAS EXPLANTED DUE TO PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11774459 ↗
• InjuryNov 5, 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 WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THE PATIENT ALSO HAD SYSTEMIC SCLEROSIS AND AN UNKNOWN LEAD ERODED THROUGH THE SKIN. THERE WAS NO ALLEGATION AGAINST THE DEVICE AND LEADS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: No Code Available; Pocket Erosion; Unspecified Infection

  MAUDE report 10796653 ↗
• 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 WAS PART OF A SYSTEM REVISION DUE TO INFECTION. IN ADDITION, THE PATIENT HAD ALSO A PULMONARY EMBOLISM AND WAS PUT ON TISSUE PLASMINOGEN ACTIVATOR AND HEPARIN. THIS RV LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Embolism; Unspecified Infection

  MAUDE report 9982018 ↗

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,