ENDOTAK RELIANCE® G 0286Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00802526431418), received between Apr 22, 2016 and Aug 16, 2026 — classified as 51 injuries, 32 malfunctions.

The most frequently reported specific device problem is “High impedance” (42 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-2326-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2026High impedance

  It was reported that this right ventricular (RV) lead exhibited high out of range shock impedances. The health care professional (HCP) called Technical Services (TS) for further review of the daily threshold and impedance measurements trend report. TS reviewed the data and confirmed the RV lead recorded high out of range shock impedance measurements which appeared to have been gradually increasing over time. At this time, this RV lead remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50267063 ↗
• InjuryJul 2, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25694723 ↗
• InjuryJun 1, 2026Adverse 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 AND POCKET EROSION. REPORTEDLY, THE PATIENT HAD A LUNG INFECTION THEN CONFIRMED THAT THE ICD WAS POKING THROUGH AND MOVING AROUND THE ARMPIT AREA. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD REMAINS IMPLANTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 25353544 ↗
• MalfunctionFeb 17, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD, IMPLANTED WITH A NON BOSTON SCIENTIFIC DEVICE, EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS. IT WAS NOTED THAT SHOCK IMPEDANCES VIA THE PROXIMAL COIL WERE WITHIN NORMAL LIMITS. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS, AND DEFIBRILLATION THRESHOLD (DFT) TESTING WAS RECOMMENDED. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373154 ↗
• InjuryJan 13, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT DURING A PULSE GENERATOR CHANGE-OUT, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AND LOSS OF CAPTURE (LOC). THE LEAD WAS TESTED USING A PACING SYSTEM ANALYZER AND THE ELEVATED THRESHOLDS PERSISTED. A REVIEW OF THE STORED DATA REVEALED THE THRESHOLD INCREASED DURING THE PREVIOUS 6 MONTHS; HOWEVER, IMPEDANCE AND SENSING MEASUREMENTS WERE NORMAL AND A CHEST X-RAY SHOWED NO ABNORMALITIES. THE TREATING PHYSICIAN PERFORMED A VENOGRAPHY THAT SHOWED THE PATIENT ANATOMY HAD A CLOSED ACCESS. THE PATIENT IS NOT PACING DEPENDENT, SO THE PHYSICIAN ELECTED TO PROGRAM RV PACING OFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD NO CAPTURE AND THERE WERE HIGH CAPTURE THRESHOLDS. LEAD FRACTURE WAS SUSPECTED. SENSING AND SHOCK IMPEDANCES WERE WITHIN THE NORMAL RANGE, AND NO NOISE WAS NOTED. SUBSEQUENTLY THIS LEAD WAS SURGICALLY ABANDONED, AND A NEW LEAD WAS SUCCESSFULLY REPLACED. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059486 ↗
• InjuryDec 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN THE PACING IMPEDANCE MEASUREMENTS. THE MEASUREMENTS REMAIN IN RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION INDICATED THAT THIS RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918947 ↗
• MalfunctionSep 11, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED A PACE IMPEDANCE MEASUREMENT OF GREATER THAN 3,000 OHMS. ADDITIONALLY, HIGH THRESHOLDS AND A GRADUAL RISE IN SHOCK IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) RECOMMENDED REPROGRAMMING. THE FIELD REPRESENTATIVE NOTED THE CLINIC IS AWARE AND IS CONTINUING TO MONITOR. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026861 ↗
• InjuryAug 11, 2025High impedance; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; High impedance; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A CLINIC VISIT, THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR FURTHER REVIEW OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TO CONFIRM DEVICE OPERATION. IT WAS NOTED THAT THE DEVICE HAD RECORDED A SUPRAVENTRICULAR TACHYCARDIA (SVT) EPISODE. UPON REVIEW, THE PRESENTING ELECTROGRAM (EGM) SHOWED THE DEVICE HAD INAPPROPRIATELY DELIVERED EIGHT BURSTS OF ANTI-TACHYCARDIA PACING (ATP) AND SIX SHOCKS IN ATTEMPT TO CONVERT THE RHYTHM. THERAPY WAS EXHAUSTED. FURTHER REVIEW OF THE SHOCKS SHOWED THAT A CODE 1005 WHICH INDICATED AN OPEN CIRCUIT CONDITION WAS TRIGGERED DUE TO HIGH OUT OF RANGE SHOCK IMPEDANCES HAD BEEN RECORDED ON THE RIGHT VENTRICULAR (RV) LEAD DURING SHOCK DELIVERY. TS REVIEWED THE DAILY IMPEDANCE TREND REPORT AND OBSERVED THAT THE RV LEAD SHOCK IMPEDANCES APPEARED TO HAVE BEEN GRADUALLY INCREASING OVER TIME TO BE GREATER THAN 125 OHMS. TS DISCUSSED POSSIBLE CAUSES WITH THE HCP, RECOMMENDING FOR THE RV LEAD TO BE REPLACED. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22772977 ↗
• 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 22650300 ↗
• 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22635741 ↗
• MalfunctionJul 11, 2025High impedance; High impedance

  THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED ELEVATED AND FLUCTUATING RIGHT VENTRICULAR (RV) LEAD IMPEDANCE FOLLOWING A GENERATOR REPLACEMENT. HISTORICAL DATA SHOWED A GRADUAL RISE IN IMPEDANCE PRIOR TO REPLACEMENT, FOLLOWED BY AN EXPECTED DROP WITH THE NEW DEVICE, THEN MINOR FLUCTUATIONS. NO PACING INHIBITION OR RV LEAD NOISE WAS OBSERVED. DUE TO THE VARIABILITY, TECHNICAL SERVICES RECOMMENDED FURTHER IN-OFFICE EVALUATION TO RULE OUT UNDER-INSERTION OR INTERMITTENT LEAD FRACTURE. SLIGHTLY ELEVATED POWER CONSUMPTION WAS ATTRIBUTED TO PERSISTENT AT/AF AND HIGH RV SENSING RATE. THE DEVICE IS DEPLETING NORMALLY, NO MALFUNCTION WAS IDENTIFIED, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480264 ↗
• MalfunctionJun 27, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR FURTHER REVIEW OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM PRESENTING ELECTROGRAM (EGM) DUE TO CONCERNS OF LOSS OF CAPTURE (LOC) ON THE RIGHT VENTRICULAR (RV) LEAD. UPON REVIEW, THE PRESENTING EGM SHOWED VARIOUS MORPHOLOGIES, TS WAS UNABLE TO CONFIRM RV CAPTURE. TS RECOMMENDED FOR THE PATIENT BE SCHEDULED FOR AN IN PERSON VISIT FOR FURTHER EVALUATION. AT THIS TIME, THE CRT-D AND RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22351532 ↗
• MalfunctionMay 8, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN OUT OF RANGE PACE IMPEDANCE MEASUREMENT GREATER THAN 3000 OHMS FOR GREATER THAN SIX MONTHS AFTER INCREASING GRADUALLY. A BOSTON SCIENTIFIC REPRESENTATIVE CHECKED THE DEVICE IN CLINIC. TECHNICAL SERVICES (TS) RECOMMENDED CONSULTING WITH THE PATIENT'S PHYSICIAN FOR NEXT STEPS. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21988577 ↗
• InjuryMar 25, 2025Signal Artifact/Noise; Fracture; Defective Device; Signal Artifact/Noise; Fracture; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689521 ↗
• InjuryFeb 25, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING OF NOISY SIGNALS. THIS RV LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458182 ↗
• MalfunctionDec 31, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING OVERSENSING AND NOISY SIGNALS. TECHNICAL SERVICES (TS) WAS CONSULTED AND EXPLAINED POSSIBLE RELATION TO ELECTROMAGNETIC INTERFERENCE (EMI). TS NOTED PACING INHIBITION FOR OVER 2 SECONDS AND SOME INTRINSIC BEATS. PATIENT IS NOT IN ATRIAL FIBRILLATION (AF). THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 21048182 ↗
• InjuryDec 4, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED REVIEW OF 2 EPISODES FOR THIS PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). FIRST, THE RIGHT VENTRICULAR (RV) LEAD FACED PACING INHIBITION FOR MORE THAN TWO SECONDS DUE TO NOISE OVERSENSING, AND THE RIGHT ATRIAL (RA) LEAD ALSO DETECTED NOISE AND OVERSENSING. SECOND, A NON-SUSTAINED VENTRICULAR TACHYCARDIA WAS TRIGGERED BY A PREMATURE VENTRICULAR CONTRACTION (PVC) THAT FELL INTO THE BLANKING PERIOD, LEADING TO AN EXTRA VENTRICULAR PACING AND SUBSEQUENTLY INITIATING AN ARRHYTHMIA. TECHNICAL SERVICES (TS) RECOMMENDED REPROGRAMMING OPTIONS AND A POSSIBLE LEAD REVISION MAY BE REQUIRED. NO ADDITIONAL ADVERSE EFFECTS ON THE PATIENT WERE REPORTED, AND THE SYSTEM REMAINS IN SERVICE.

  Patient problems: Arrhythmia; Asystole

  MAUDE report 20846783 ↗
• InjuryApr 14, 2024Fracture; High impedance; Pacing Problem; Fracture; High impedance; Pacing Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACE IMPEDANCE MEASUREMENTS ALONG WITH A LACK OF RV PACING THEREFORE NO BIVENTRICULAR PACING WAS AVAILABLE TO THIS PATIENT. A LEAD FRACTURE WAS SUSPECTED DUE TO THE HIGH IMPEDANCES HOWEVER WAS NOT VISUALIZED ON FLUOROSCOPY. THIS RV LEAD WAS EXPLANTED AND REPLACED WITH A NEW RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103026 ↗
• InjuryDec 20, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED DUE TO EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. ANOTHER LEAD WAS IMPLANTED INSTEAD. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18366129 ↗
• MalfunctionAug 2, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS, MEASURING GREATER THAN 145 OHMS. UPON REVIEW, THERE WAS A GRADUAL INCREASE IN THE IMPEDANCES OVER THE PAST YEAR. THE PLAN IS TO CONTINUE MONITORING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17439912 ↗
• InjuryJun 13, 2023Adverse 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 SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17122465 ↗
• MalfunctionMay 11, 2023High impedance; High impedance

  THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCK IMPEDANCES OUT OF RANGE. THE PATIENT WILL BE SEEING IN THE CLINIC THE NEXT MONTH. UPON INTERROGATION AND VECTOR BREAKDOWN, BOTH RIGHT ATRIAL (RA) TO CAN AND RV TO RA ARE OUT OF RANGE. IT WAS RECOMMENDED TO REPROGRAM TO RV TO CAN AND MONITOR. ADDITIONALLY, IT WAS RECOMMENDED TO CONSIDER PERFORMING A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) NOW THAT IN A DIFFERENT VECTOR TO CONFIRM VENTRICULAR FIBRILLATION (VF) CONVERSION. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913930 ↗
• InjuryMar 27, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED RIGHT VENTRICULAR (RV) LOSS OF CAPTURE WHEN PROGRAMMED AT MAXIMUM OUTPUTS. ADDITIONALLY, THE PATIENT WAS EXPERIENCING HYPOTENSION. SUBSEQUENTLY, THE ICD WAS EXPLANTED AND REPLACED, AND A TEMPORARY RV LEAD WAS USED, AND A NEW RV LEAD WAS IMPLANTED. THE EXISTING RV LEAD WAS SURGICALLY ABANDONED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 16618639 ↗
• InjuryNov 30, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD SHOWED A GRADUAL INCREASE IN THE SHOCK IMPEDANCE INTO HIGH, OUT OF RANGE (OOR) VALUES. A DELIVERED SHOCK REGISTERED A NORMAL SHOCK IMPEDANCE, BUT THE DAILY MEASUREMENTS KEEP SHOWING OOR VALUES. A COMMANDED SHOCK, DEFIBRILLATION THRESHOLD (DFT) TEST WAS SUGGESTED TO TEST ABILITY TO CHARGE AND DELIVER WITHOUT AN OPEN CIRCUIT FAULT. THE PATIENT UNDERWENT THE DFT PROCEDURE. THE DEVICE CONVERTED VENTRICULAR FIBRILLATION, DESPITE THE HIGH SHOCK IMPEDANCE. SO, NO FURTHER ACTION WAS TAKEN. THE RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 15884898 ↗
• MalfunctionOct 21, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED OF DAMAGE OF THE SHOCK LEAD AS SHOWN ON THE X-RAY PHOTOGRAPH. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REQUESTED FOR A CONFIRMATION. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650490 ↗

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-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,