ENDOTAK RELIANCE® G 0185Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,632 adverse event reports that list this exact device (DI 00802526531194), received between Apr 2, 2015 and Aug 5, 2026 — classified as 9 deaths, 1,136 injuries, 487 malfunctions.

The most frequently reported specific device problem is “High impedance” (881 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 1,632 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026High impedance

  It was reported that a review of the right ventricular (RV) lead showed evidence of a gradual increase in shock impedance that remains within normal limits. Technical Services provided troubleshooting recommendations, and reprogramming options were discussed. It was decided that the lead would be surgically abandoned and replaced. Additionally, a segment of the lead was returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50148297 ↗
• MalfunctionJul 31, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098306 ↗
• MalfunctionJul 30, 2026High impedance; Off-Label Use

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50088158 ↗
• MalfunctionJul 13, 2026High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED A RED CALL DOCTOR (RCD). TROUBLESHOOTING WAS PERFORMED. THE RCD RECORDED WAS FOR HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25804484 ↗
• MalfunctionApr 21, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED SUDDEN HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ABOVE 3000 OHMS IN THE RIGHT VENTRICULAR (RV) LEAD CHANNEL. TECHNICAL SERVICES (TS) WAS CONSULTED AND FURTHER IN OFFICE AND X-RAY EVALUATION WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24947983 ↗
• InjuryApr 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE ALLERGIC REACTION AND ITCHING ISSUE. REPORTEDLY, THE PATIENT HAD A SEVERE ITCHING AND ALLERGY PROBLEM DUE TO METAL MATERIALS OF THE PACEMAKER. THE PATIENT WAS THEN TRANSFERRED TO THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) GROUP. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD REMAINS IMPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 24785513 ↗
• InjuryMar 2, 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 STAPHYLOCOCCUS INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 24490492 ↗
• InjuryFeb 2, 2026High impedance; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236161 ↗
• MalfunctionDec 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LEAD DISLODGEMENT. THE CLINICIAN PREVIOUSLY INFORMED THE PATIENT AFTER GENERATOR CHANGEOUT THAT THIS LEAD WHICH WAS STICKING UP CAN BE FIXED IF BOTHERING. THE PATIENT WAS CONCERNED AS THE CAR SEATBELT RUBS THE AREA WHERE THE LEAD IS. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT ADVISED TO CONTACT THE CLINICIAN AND REVIEWED TRANSMISSION REPORT INDICATING NO FAULTS, ELECTIVE REPLACEMENT INDICATOR NOTIFICATION NOR OUT OF RANGE VALUES. AS OF THIS TIME, THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23833574 ↗
• InjuryOct 24, 2025High impedance; Connection Problem; High impedance; Connection Problem

  IT WAS REPORTED THAT DURING A ROUTINE CHECKUP VISIT A WEEK POST GENERATOR REPLACEMENT PROCEDURE, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WAS OBSERVED TO EXHIBIT HIGH OUT OF RANGE SHOCK IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED FOR FURTHER REVIEW OF THE DAILY THRESHOLD AND IMPEDANCE MEASUREMENTS. TS REVIEWED THE REPORTS AND CONFIRMED RV LEAD SHOCK IMPEDANCES TO HAVE BEEN STABLE WITH THE OLD GENERATOR, HOWEVER THOSE RV LEAD IMPEDANCES APPEARED TO HAVE INCREASED TO BE GREATER THAN 125 OHMS WITH THE NEW ICD DEVICE. TS DISCUSSED POSSIBLE CAUSES AND RECOMMENDED FOR FURTHER EVALUATION TO BE PERFORMED. AT THIS TIME, THE ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT A FOLLOW UP VISIT WAS PERFORMED WHERE XRAY IMAGES WERE TAKEN. IT WAS SUSPECTED THAT THE RV LEAD TO HAVE DISLODGED AT THE PIN SITE OR POSSIBLE CONNECTION ISSUE HOWEVER THE IMAGES WERE UNCLEAR. TECHNICAL SERVICES (TS) RECOMMENDED FOR FURTHER EVALUATION LIKE TUG TEST TO BE COMPLETED. THE CLINICIAN PLANS ON SCHEDULING PATIENT FOR AN IN PERSON VISIT FOR FURTHER EVALUATION. AT THIS TIME, NO ADDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381449 ↗
• MalfunctionOct 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHOCK LEAD IMPEDANCE OUT OF RANGE. THE SUSPECTED CAUSE IS SPRING CONTACT OR FRACTURE BUT IS NOT CONFIRM. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23362839 ↗
• InjurySep 9, 2025High impedance; Nonstandard Device; High impedance; Nonstandard Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH WITHIN RANGE SHOCK IMPEDANCES MEASUREMENTS AROUND 67 OHMS. THE PHYSICIAN OPTED TO EXPLANT AND REPLACE THIS LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD HAS NOT BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009967 ↗
• 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 22671297 ↗
• 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 22669222 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666119 ↗
• 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. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL RISE IN SHOCK IMPEDANCES SINCE 2023. THE FIELD REPRESENTATIVE NOTED THIS PATIENT DID NOT PASS IN INITIAL POLARITY. ULTIMATELY, THE DEVICE WAS EXPLANTED DUE TO A NORMAL GENERATOR CHANGE. DURING THE CHANGE OUT PROCEDURE DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED WITH INITIAL POLARITY AND TRIAD CONFIGURATION. THE FIRST ATTEMPT WAS UNSUCCESSFUL IN INITIAL POLARITY AND A SECOND AND THIRD ATTEMPT WERE BOTH SUCCESSFUL, WITH IN RANGE SHOCK IMPEDANCE MEASUREMENTS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22635569 ↗
• MalfunctionJul 25, 2025High impedance; High impedance

  IT WAS REPORTED THAT THERE WAS A GRADUAL RISE IN SHOCK LEAD IMPEDANCES. AT IMPLANT IMPEDANCE MEASURED 50 OHMS AND NOW IMPEDANCES MEASURE 117 OHMS. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING OPTIONS. AT THIS TIME, THE LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED 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 22609063 ↗
• InjuryJul 8, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. NO OTHER INFORMATION WAS PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22443421 ↗
• InjuryJul 7, 2025Signal Artifact/Noise; Failure to Capture; Signal Artifact/Noise; Failure to Capture

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXHIBITING INTERMITTENT RIGHT VENTRICULAR (RV) LEAD LOSS OF CAPTURE. TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED ELECTROMAGNETIC INTERFERENCE (EMI), THE PATIENT HAS A LEFT VENTRICULAR ASSIST DEVICE. THIS CRT-D SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND THERE HAS NOT BEEN RIGHT ATRIAL (RA) LEAD CAPTURE FOR SEVERAL MONTHS, AND THE RIGHT VENTRICULAR (RV) LEAD WAS REPORTED TO NOT BE WORKING WELL. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED REPROGRAMMING OPTIONS. TACHY THERAPY HAD BEEN TURNED OFF. THIS CRT-D SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413123 ↗
• InjuryMay 5, 2025Fracture; High impedance; Defective Device; Fracture; High impedance; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO A PRODUCT PERFORMANCE ISSUE. THIS LEAD HAS NOT BEEN RECEIVED FOR ANALYSIS. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Twiddlers Syndrome

  MAUDE report 21963740 ↗
• InjuryOct 1, 2024Adverse 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. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20349481 ↗
• InjuryOct 1, 2024Adverse 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 POCKET EROSION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD STILL REMAINS IN SERVICE.

  Patient problems: Unspecified Infection

  MAUDE report 20348458 ↗
• InjuryAug 8, 2024Adverse 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. THIS RV LEAD WAS EXPLANTED. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE INDICATED THAT THE PATIENT HAD A DEHISCENCE AND FLUID DISCHARGE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Fluid Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 19946261 ↗
• MalfunctionAug 2, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM OVERSENSED NOISE ON THE RIGHT VENTRICULAR (RV) LEAD, WHICH RESULTED IN PACING INHIBITION AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). THE PATIENT EXPERIENCED GREATER THAN TWO SECONDS OF ASYSTOLE. TECHNICAL SERVICES (TS) REVIEWED THE STORED EPISODES AND NOTED THE NOISE WAS SUGGESTS OF ELECTROMAGNETIC INTERFERENCE (EMI), HOWEVER, THE CAUSE OF THE EMI IS UNKNOWN. THIS CRT-D SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT WAS SEEN IN CLINIC DUE TO THE RECURRENCE OF EMI SUGGESTIVE EPISODES. THE PATIENT BROUGHT IN THEIR CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) MACHINE; HOWEVER, THE NOISE WAS UNABLE TO BE REPRODUCED. IT WAS SPECULATED THAT THE DEVICE COULD BE SENSING ATRIAL SIGNALS, BUT NOT CONFIRMED. IT WAS NOTED THAT NO FURTHER ACTION WOULD BE TAKEN AT THIS TIME. THIS CRT-D SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 19893956 ↗
• InjuryJul 10, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 135 OHMS. IT WAS ALSO NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRTD) IS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND A CHANGEOUT WAS PLANNED. ADDITIONALLY, NO NOISE COULD BE SEEN, AND RV PACE IMPEDANCE WAS WITHIN NORMAL LIMITS. TECHNICAL SERVICES (TS) RECOMMENDED A MAX ENERGY R WAVE SYNCH SHOCK AND IF A CODE 1005 INDICATIVE OF AN OPEN CIRCUIT CONDITION DURING SHOCK DELIVERY IS RECORDED THEN LEAD REPLACEMENT WAS RECOMMENDED, HOWEVER IF AFTER THE SHOCK THE SHOCKING IMPEDANCES ARE WITHIN RANGE THE PHYSICIAN CAN CONSIDER MONITORING THE LEAD. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, AN ENERGY SHOCK TO THE EXISTING LEAD WAS PERFORMED AND MEASUREMENTS WERE ACCEPTED. THE CRTD WAS REPLACED DUE TO NORMAL BATTERY DEPLETION AND THIS LEAD REMAINS IN SERVICE WITH THE NEW CRTD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710212 ↗

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,