RELIANCE 4-FRONT™ 0675Recalls & reported problems

Summary

The FDA's MAUDE database contains 301 adverse event reports that list this exact device (DI 00802526496981), received between Jan 22, 2019 and Sep 23, 2026 — classified as 3 deaths, 255 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 301 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited shock impedance measurements high out of range. Subsequently, this lead was capped 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 50873614 ↗
• InjurySep 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 50713627 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50573392 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this right ventricular (RV) lead was explanted with less than a year of use due to an infection. A new subcutaneous implantable cardioverter defibrillator (S-ICD) system was implanted and remains in service. No additional adverse patient effects were reported.

  Patient problems: Unspecified Infection

  MAUDE report 50280347 ↗
• InjuryAug 13, 2026High Capture Threshold

  It was reported that this recently implanted right ventricular (RV) lead exhibited high capture thresholds. Technical Services (TS) was consulted and determined the measurements rose overnight and due to the patient being dependent, the physician and local field representative opted to reposition the lead. TS discussed programming the system to the left ventricular only but advised against it as the RV port would remain active and could cause oversensing of signals and reset timing cycles. TS recommended using cautery mode due to the system being biventricular. No additional adverse patient effects were reported. This RV lead remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237357 ↗
• InjuryAug 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 around the incision site. There was no additional adverse patient effects reported. The RV lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50209663 ↗
• InjuryAug 3, 2026Failure to Capture; Failure to Convert Rhythm; Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead exhibited a product performance issue. The patient underwent a medical intervention to surgically abandon the lead and implant a new product. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50114981 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable lead was part of the system revision due to infection. Furthermore, the patient received a temporary pacing system. No adverse patient effects were reported. The implantable lead was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50066997 ↗
• InjuryJul 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 25741925 ↗
• InjuryJun 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 25464032 ↗
• 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. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25176407 ↗
• MalfunctionMay 14, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED A GRADUAL RISE WITH HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. ADDITIONALLY, THE PATIENT EXPERIENCED PAIN DURING THE RIGHT VENTRICULAR (RV) THRESHOLD TEST. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON DATA REVIEW IDENTIFIED HIGH CAPTURE THRESHOLDS. THIS RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 25172672 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED INFECTION. A REVISION WAS PERFORMED AND THE ICD, ALONG WITH THE RV LEAD WERE EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAF WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Unspecified Infection

  MAUDE report 25056227 ↗
• InjuryApr 29, 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 25035186 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24876043 ↗
• InjuryMar 19, 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 24643361 ↗
• MalfunctionFeb 23, 2026High impedance

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH GRADUAL RISING SHOCK IMPEDANCES WITHIN NORMAL RANGE. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24419488 ↗
• InjuryJan 22, 2026Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD IS SHORT-CIRCUITING CAUSING THE ATRIUM TO FIRE FASTER THAN THE VENTRICLES. THE PATIENT INDICATED THAT THEIR HEALTH CARE PROFESSIONAL (HCP) SCHEDULED AN ABLATION PROCEDURE AND IF THAT WAS SUCCESSFUL THAT ANOTHER LEAD WOULD BE PLACED. AT THIS TIME, THIS LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 24147636 ↗
• InjuryJan 8, 2026High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THRESHOLD IN LATITUDE WITH HEALTH CARE PROFESSIONAL (HCP). THIS RV LEAD WAS SURGICALLY ABANDONED. A NEW RV LEAD WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012641 ↗
• InjuryJan 7, 2026Over-Sensing; Pacing Problem; Failure to Read Input Signal; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED OVERSENSING AND LOW R-WAVE AMPLITUDES ON THE RIGHT VENTRICULAR (RV) CHANNEL. AS A RESULT, THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). IN ADDITION TO THE OVERSENSING, P-WAVES WERE VISIBLE ON THE SHOCK CHANNEL. TECHNICAL SERVICES (TS) SUSPECTED THE LEAD HAD DISLODGED AND RECOMMENDED PERFORMING AN X-RAY, THAT WOULD LIKELY RESULT IN A LEAD REVISION. SUBSEQUENTLY, THIS RV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, AND THIS RV LEAD HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23996643 ↗
• InjuryDec 21, 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23860500 ↗
• 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 THE SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23695024 ↗
• MalfunctionNov 19, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOW OUT OF RANGE SHOCK IMPEDANCES. THE SHOCK LEAD IMPEDANCE DROPPED FROM 50 OHMS DOWN TO 0 OHMS AND CAME BACK UP. THE RV PACE IMPEDANCES ALSO DROPPED BUT STAYED WITHIN NORMAL LIMITS. TECHNICAL SERVICES (TS) SKED IF THE PATIENT UNDERWENT A PROCEDURE DURING THAT TIME OR TO POTENTIALLY BRING THE PATIENT IN TO CLINIC FOR FURTHER TESTING. THIS RV LEAD AND ICD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597132 ↗
• InjuryNov 18, 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23586221 ↗
• InjuryNov 13, 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23546995 ↗

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,