ENDOTAK RELIANCE® SG 0181Recalls & reported problems

Summary

The FDA's MAUDE database contains 651 adverse event reports that list this exact device (DI 00802526531156), received between Oct 4, 2013 and Aug 25, 2026 — classified as 3 deaths, 393 injuries, 255 malfunctions.

The most frequently reported specific device problem is “High impedance” (388 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 651 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited high out of range shock impedance measurements for its right ventricular (RV) lead. Technical Services (TS) was consulted and discussed stored data as well as measurements trends, with TS recommending the measurements to continue to be monitored. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50424462 ↗
• MalfunctionJul 27, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50042952 ↗
• MalfunctionJul 21, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25899839 ↗
• InjuryJun 24, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN SHOCK IMPEDANCE MEASUREMENTS. A REVISION PROCEDURE WAS PERFORMED WHERE THIS RV LEAD WAS EXPLANTED. ONCE THE LEAD WAS REMOVED, UPON VISUAL INSPECTION, THE SHOCKING COIL WAS OBSERVED TO HAVE DENSE CALCIFICATION ON THE ENTIRETY OF THE SHOCK COIL. A NEW LEAD WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS RETURNED TO FACILITY AWAITING ANALYSIS.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 25616104 ↗
• InjuryJun 10, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD HAD BEEN RECENTLY HOSPITALIZED DUE TO PAIN THAT BEGAN APPROXIMATELY SIX MONTHS PRIOR AND EXPRESSED CONCERNS REGARDING ELEVATED SHOCK IMPEDANCE MEASUREMENTS; HOWEVER, NO MEASUREMENTS OUT OF RANGE WERE OBSERVED. TECHNICAL SERVICES (TS) REVIEWED THE INFORMATION AND INDICATED THAT CONTINUED MONITORING IS RECOMMENDED. THE TIMING OF THE NEXT OFFICE VISIT WAS REFERRED TO THE MANAGING PHYSICIAN FOR PATIENT SPECIFIC GUIDANCE. THIS RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 25461057 ↗
• MalfunctionApr 28, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL RISE IN SHOCK IMPEDANCE MEASUREMENTS OUT OF RANGE. TECHNICAL SERVICES (TS) REVIEWED AND STATED THERE WAS LIKELY CALCIFICATION ON THE LEAD. TS RECOMMENDED TO HAVE A LEAD REPLACEMENT. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 25017809 ↗
• MalfunctionApr 9, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD RECORDED AN ALERT FOR HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) REVIEWED THE AVAILABLE DEVICE DATA AND OBSERVED THE REPORTED SHOCK IMPEDANCE VALUE WAS APPROXIMATELY 125 OHMS. TS RECOMMENDED CONSIDERATION OF INCREASING THE UPPER ALERT LIMIT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835507 ↗
• MalfunctionMar 30, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Data Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WITH THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING ON THE VENTRICULAR CHANNEL, RESULTING IN PACING INHIBITION GREATER THAN TWO SECONDS DURING A STORED VENTRICULAR EPISODE. THE PATIENT WAS REPORTED TO BE PACING DEPENDENT. TECHNICAL SERVICES (TS) REVIEWED THE SHOCK IMPEDANCE HISTORY AND INDICATED THAT THERE WERE NO SIGNS OF A GRADUAL RISE SUGGESTIVE OF A PROGRESSIVE LEAD INTEGRITY ISSUE; HOWEVER, SOME GAPS IN THE DATA WERE NOTED. TS REVIEWED THE STORED EPISODE AND INDICATED THAT THE NOISY SIGNALS APPEARED MORE CONSISTENT WITH DIAPHRAGMATIC ACTIVITY RATHER THAN A LEAD INTEGRITY ISSUE. REVIEW OF RATE COUNTERS SHOWED NUMEROUS SENSED EVENTS AT RATES GREATER THAN 250 BEATS PER MINUTE (BPM) DESPITE A LIMITED NUMBER OF STORED VENTRICULAR EPISODES, SUGGESTING THAT OVERSENSING MAY BE OCCURRING MORE THAN THE TOTAL NUMBER OF STORED EPISODES INDICATES. THE FIELD REPRESENTATIVE REPORTED THAT PROGRAMMING OPTIMIZATION WAS PERFORMED AND THAT SIMILAR NOISE COULD BE REPRODUCED DURING DEEP BREATHING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE. ADDITIONAL INFO

  Patient problems: Asystole

  MAUDE report 24708887 ↗
• InjuryMar 20, 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 24653556 ↗
• MalfunctionJan 30, 2026Signal Artifact/Noise; High 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. IT WAS NOTED THAT THE PATIENT HAS A BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD WITH A NON-BOSTON SCIENTIFIC SUBCUTANEOUS COIL IMPLANTED. TS REVIEWED THE DAILY THRESHOLD AND IMPEDANCE MEASUREMENTS TREND REPORT AND DETERMINED AN ABRUPT INCREASE IN SHOCK IMPEDANCES FROM 40 TO 140 OHMS. TS DISCUSSED SUSPECTED CAUSE AND PROVIDED PROGRAMMING RECOMMENDATIONS. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD AND NON-BOSTON SCIENTIFIC SUBCUTANEOUS COIL REMAIN IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED TECHNICAL SERVICES (TS) WAS CONTACTED FOR FURTHER REVIEW OF THE STORED ELECTROGRAM (EGM) DUE TO THE HIGH OUT OF RANGE SHOCK IMPEDANCES ON THE RV LEAD. TS REVIEWED THE EGM AND NOTED NOISE ON THE SHOCK CHANNEL. TS DISCUSSED POSSIBLE CAUSES AND RECOMMENDED FOR THE LEAD TO BE FURTHER EVALUATED THROUGH ISOMETRICS AND POSSIBLY XRAY IMAGING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228686 ↗
• InjuryDec 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WHICH WERE ATTRIBUTED CALCIUM BUILD UP. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RV LEAD HAD BEEN EXPLANTED AND REPLACED. AT THIS TIME, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED, AND THIS RV LEAD HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 23916972 ↗
• InjuryDec 18, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO THE POTENTIAL OF GRADUALLY RISING SHOCK LEAD IMPEDANCES. A NEW CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS IMPLANTED AS A REPLACEMENT. THIS LEAD HAS NOT BEEN RECEIVED FOR INVESTIGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846779 ↗
• InjuryDec 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN CAUSE. THE RV LEAD WAS REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711429 ↗
• MalfunctionNov 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE FIELD CLINICAL REPRESENTATIVE THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STATED EXPERIENCING A PIERCING SENSATION AROUND THE DEVICE, DESPITE ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS AND POWER CONSUMPTION REMAINED STABLE AT 97 PERCENT. TS ASSESSED AND INDICATED THAT THE SYMPTOM HAD OCCURRED BEFORE BUT DID NOT PERSIST. TS DOCUMENTED THE PATIENT'S PRODUCT EXPERIENCED REPORT WITH THE SENSATION THAT WAS LOCALIZED TO THE RIGHT EDGE OF THE DEVICE. ADDITIONALLY, THE PATIENT STATED HEARING A HIGH-FREQUENCY SOUND. TO DATE, THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Implant Pain

  MAUDE report 23577531 ↗
• InjuryOct 24, 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 SURGICALLY ABANDONED.

  Patient problems: Unspecified Infection

  MAUDE report 23386415 ↗
• MalfunctionOct 15, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN SHOCK IMPEDANCE MEASUREMENTS, REACHING 135 OHMS. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROGRAMMING OPTIONS WERE ADVISED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23296523 ↗
• MalfunctionSep 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAS EXHIBITED GRADUALLY INCREASING SHOCK IMPEDANCE MEASUREMENTS, WITH THE MOST RECENT VALUE BEING OUT-OF-RANGE (140 OHMS). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND DISCUSSED THAT THIS LEAD IMPEDANCE HAD BEEN STABLE UNTIL 2020, WHERE IT BEGAN GRADUALLY INCREASING. AS THE SHOCK IMPEDANCE HAD NOT EXCEEDED 150 OHMS, TS RECOMMENDED CONTINUING WITH MONITORING WITH ALL SHOCKS PROGRAMMED TO THE MAXIMUM ENERGY (41 J), IF CLINICALLY APPROPRIATE. AT THIS TIME, THE RV LEAD REMAINS IMPLANTED AND IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23176314 ↗
• InjurySep 25, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD HIGH OUT OF RANGE SHOCK IMPEDANCE. TECHNICAL SERVICES (TS) REVIEWED THE EPISODE, AND IT SHOWED THAT THE IMPEDANCE HAD BEEN GRADUAL RISING. SUBSEQUENTLY, THIS PATIENT UNDERWENT A REPLACEMENT PROCEDURE, AND THIS RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23143042 ↗
• MalfunctionAug 5, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. TECHNICAL SERVICES (TS) DETERMINED THE RISE WAS GRADUAL AND RECOMMENDED REPROGRAMMING OPTIONS. THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715575 ↗
• 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 22669269 ↗
• InjuryJul 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. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED WITH A NEW RV LEAD. A RETURN REQUEST IS BEING SENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668162 ↗
• 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 22666082 ↗
• 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 22664031 ↗
• 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 22651305 ↗
• 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 22651259 ↗

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-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