ENDOTAK RELIANCE® SG 0170Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00802526373282), received between Aug 2, 2016 and Mar 4, 2026 — classified as 10 injuries, 9 malfunctions.

The most frequently reported specific device problem is “High impedance” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. Jul 24, 2025Class IOpen, Classified

   Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.

   Z-2325-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Impedance Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD WAS EXPLANTED DUE TO A NONSPECIFIC PRODUCT PERFORMANCE ISSUE. THIS RV LEAD HAS NOT BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24509116 ↗
• MalfunctionAug 6, 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. INFORMATION WAS SUBSEQUENTLY RECEIVED THAT STORED DATA ASSOCIATED WITH THIS LEAD WAS EVALUATED BY TECHNICAL SERVICES (TS). THE REVIEW NOTED THE LEAD HAD BEEN CONNECTED TO TWO PULSE GENERATORS FROM DIFFERENT MANUFACTURERS AND THAT WITH THE MOST RECENT PULSE GENERATOR HAD RECORDED INCREASED IMPEDANCE VALUES FROM APPROXIMATELY 80 OHMS TO OUT OF RANGE VALUES OF GREATER THAN 125 OHMS AND HAD REMAINED NEAR THAT LEVEL. A CHANGE IN PROGRAMMING POLARITY AND WAS RECOMMENDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728973 ↗
• 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 22668160 ↗
• InjuryMay 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. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTIC. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21996121 ↗
• MalfunctionMay 8, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED A GRADUAL RISE IN SHOCK IMPEDANCES TO HIGH OUT-OF-RANGE MEASUREMENTS GREATER THAN 125 OHMS, WITH MEASUREMENTS AS HIGH AS 146 OHMS. IT WAS NOTED THAT THIS TREND BEHAVIOR WAS CONSISTENT WITH LEAD CALCIFICATION. THE LAST DELIVERED SHOCK IMPEDANCE WAS 48 OHMS, WHICH OCCURRED AT IMPLANT. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING/PROGRAMMING OPTIONS, INCLUDING MAX ENERGY SHOCKS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS OR INTERVENTIONS WERE REPORTED AT THIS TIME.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 21989354 ↗
• InjuryOct 18, 2024Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE (LOC) AND ELEVATED THRESHOLD MEASUREMENTS, WITH A RECENT THRESHOLD MEASUREMENT OF 5.5V @ 1MS. SENSING AND IMPEDANCE MEASUREMENTS WERE STABLE, AND THE PATIENT WAS SCHEDULED FOR DEFIBRILLATION THRESHOLD (DFT) TESTING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT DFT TESTING WAS SUCCESSFUL; 14 J, 57 OHMS, AND 2.5 SECOND CHARGE TIME. THIS RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20487398 ↗
• MalfunctionSep 26, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 135 OHMS. THE DEVICE EXHIBITED SHOCK IMPEDANCE ALERT A MONTH BACK. TECHNICAL SERVICES (TS) RECOMMENDED TO INCREASE THE SHOCK IMPEDANCE ALERT RANGE. THIS RV LEAD REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818081 ↗
• MalfunctionMay 18, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS DATING BACK TO TWO THOUSAND AND FIFTEEN. THE ICD IS AT ELECTIVE REPLACEMENT INDICATOR (ERI). TECHNICAL SERVICES (TS) DISCUSSED POSSIBLE SHOCK TEST FOR IMPEDANCES AND GO FROM THERE. THIS RV LEAD AND ICD REMAIN IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 16954989 ↗
• MalfunctionNov 16, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. REPROGRAMING OF THE DEVICE WAS DISCUSSED. THIS LEAD REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15808442 ↗
• InjuryJul 29, 2022High impedance; Inappropriate/Inadequate Shock/Stimulation; Defective Device; High impedance; Inappropriate/Inadequate Shock/Stimulation; Defective Device

  IT WAS REPORTED THAT THE LEAD WAS EXPLANTED AS THE LEAD CONDUCTOR WAS VISIBLY EXTERNALIZED. THE EXTERNALIZED CONDUCTOR WAS CONFIRMED VIA FLUOROSCOPY. THE LEAD WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15129157 ↗
• MalfunctionJan 6, 2021High impedance; High impedance

  IT WAS REPORTED THAT THE SHOCK LEAD IMPEDANCE WAS OUT-OF-RANGE AT 150 OHMS AND HAD BEEN INCREASING OVER THE PAST SEVERAL MONTHS. AT THIS TIME, THIS RIGHT VENTRICULAR LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11128059 ↗
• InjuryApr 9, 2020Signal Artifact/Noise; Fracture; High impedance; Defective Device; High Capture Threshold; Signal Artifact/Noise; Fracture; High impedance; Defective Device; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCES, MEASURING GREATER THAN 3000 OHMS. IT WAS NOTED THE LEAD WAS FRACTURED, AND THERE WAS INSULATION DAMAGE. IN ADDITION, HIGH PACING THRESHOLDS, AND NOISE WAS OBSERVED. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9947197 ↗
• InjuryApr 3, 2020High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO AN INCREASED ON THE PACING THRESHOLDS. THIS LEAD WAS REPLACED. A SURGICAL INTERVENTION WAS NECESSARY TO RESOLVE THE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9924658 ↗
• InjuryJan 3, 2020High impedance; High impedance

  IT WAS REPORTED THAT THIS LEAD EXHIBITED OUT OF RANGE SHOCK IMPEDANCE. LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9547838 ↗
• InjuryJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION AND EROSION WITH SEPSIS. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Pocket Erosion; Sepsis; Unspecified Infection

  MAUDE report 8794021 ↗
• MalfunctionApr 12, 2019High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD, MEASURING GREATER THAN 125 OHMS. IT WAS NOTED THE PACING IMPEDANCES HAD ALSO INCREASED, HOWEVER, IT MINIMALLY INCREASED ABOUT 200 OHMS TO 250 OHMS HIGHER. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED INCREASING THE UPPER OUT OF RANGE ALERT TO 150 OHMS AND CONTINUING TO MONITOR. THIS ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8509787 ↗
• MalfunctionJan 28, 2019High impedance; High impedance

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED AN ALERT FOR HIGH OUT OF RANGE PACE IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD A FEW MONTHS AFTER IMPLANT. THE IMPEDANCES WERE AROUND 900-1000 OHMS INITIALLY, THEN INCREASED TO 1800-1900 OHMS UNTIL THEY BECAME OUT OF RANGE. TROUBLESHOOTING WAS DISCUSSED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES AND THE PATIENT WAS BROUGHT IN FOR FURTHER EVALUATION. THRESHOLDS WERE STABLE AND ISOMETRIC TESTS DID NOT PRODUCE ANY ANOMALIES. THE ALERT LIMIT WAS INCREASED FROM 2000 TO 2250 OHMS. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8283269 ↗
• InjuryApr 27, 2017Fracture; Over-Sensing; Pacing Problem; Ambient Noise Problem; Fracture; Over-Sensing; Pacing Problem; Ambient Noise Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD DISPLAYED NOISE, OVERSENSING AND PACING INHIBITION WHICH RESULTED IN GREATER THAN TWO SECONDS OF ASYSTOLE FOR THE PATIENT. A LEAD FRACTURE WAS SUSPECTED BUT NOT CONFIRMED. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE LEAD WAS EXPLANTED AND REPLACED. THE DEVICE REMAINS IN SERVICE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6526087 ↗
• InjuryAug 2, 2016Fracture; Over-Sensing; Pacing Problem; Ambient Noise Problem; Fracture; Over-Sensing; Pacing Problem; Ambient Noise Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD AND THE ASSOCIATED DEVICE DISPLAYED NOISE, OVERSENSING AND PACING INHIBITION. THE PATIENT WAS SEEN FOR A REVISION PROCEDURE WHERE THE PHYSICIAN SUSPECTED A LEAD FRACTURE. THE PACE/SENSE PORTION OF THE LEAD WAS SURGICALLY ABANDONED; A NEW PACE/SENSE LEAD WAS ADDED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5840221 ↗

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