ENDOTAK RELIANCE® SG 0180Recalls & reported problems

Summary

The FDA's MAUDE database contains 436 adverse event reports that list this exact device (DI 00802526531149), received between Jan 20, 2016 and Jul 31, 2026 — classified as 2 deaths, 282 injuries, 152 malfunctions.

The most frequently reported specific device problem is “High impedance” (271 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 436 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Fracture; Insufficient Device Problem Information

  It was reported that this right ventricular (RV) lead exhibited a nonspecific product performance anomaly. Subsequently, 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 50100695 ↗
• MalfunctionFeb 17, 2026High impedance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364337 ↗
• MalfunctionFeb 9, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD IS EXHIBITING AN INCREASE IN THRESHOLDS AND LOSS OF CAPTURE (LOC). THE LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298674 ↗
• InjuryJan 27, 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 24195945 ↗
• InjuryDec 30, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. NOISE ON THE PRESENTING AND STORED ELECTROGRAMS (EGMS) WAS ALSO NOTED. INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) DUE TO NOISE OVERSENSING WAS DETERMINED. RV LEAD REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924137 ↗
• InjuryDec 17, 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 23829983 ↗
• InjuryOct 15, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL RISE IN SHOCK IMPEDANCE MEASUREMENTS, REACHING VALUES OF 136 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED AND CONTINUE TO MONITOR WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23296462 ↗
• MalfunctionAug 13, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS, WITH THE INCREASE BEEN GRADUAL. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA AS WELL AS PROGRAMMED SETTINGS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796236 ↗
• InjuryJul 31, 2025High impedance; Nonstandard Device; High impedance; Nonstandard Device

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND RETURNED AND IS EXPECTED TO BE ANALYZED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675432 ↗
• MalfunctionJul 31, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673823 ↗
• MalfunctionJul 31, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22673617 ↗
• MalfunctionJul 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668163 ↗
• MalfunctionJul 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22665632 ↗
• InjuryJul 30, 2025High impedance; Inappropriate/Inadequate Shock/Stimulation; High impedance; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT WAS SHOCKED TWICE DUE TO SUPRAVENTRICULAR TACHYCARDIA (SVT) OR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). TECHNICAL SERVICES (TS) RECOMMENDED THIS LEAD BE REPLACED. THIS LEAD WAS SUBSEQUENTLY SURGICALLY ABANDONED AND REPLACED. OTHER THAN THE SURGICAL PROCEDURE AND INAPPROPRIATE SHOCKS, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 22663064 ↗
• MalfunctionJul 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650311 ↗
• MalfunctionJul 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650286 ↗
• MalfunctionJul 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646856 ↗
• InjuryJul 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED WITH A NEW RV LEAD. A RETURN REQUEST WILL BE SENT TO THE FIELD FOR THIS RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646849 ↗
• MalfunctionJul 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THIS LEAD EXHIBITED A GRADUAL RISE IN SHOCK IMPEDANCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645779 ↗
• InjuryJul 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645021 ↗
• MalfunctionJul 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644946 ↗
• MalfunctionJul 28, 2025High impedance; High impedance

  IT WAS REPORTED THAT UPON REVIEW OF BOSTON SCIENTIFIC LATITUDE REMOTE MONITORING SYSTEM STORED DATA, WE IDENTIFIED EVIDENCE THAT THIS LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

  Patient problems: Calcium Deposits/Calcification; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636479 ↗
• MalfunctionApr 17, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858373 ↗
• MalfunctionApr 17, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21855423 ↗
• MalfunctionApr 17, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853326 ↗

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