ENDOTAK RELIANCE® S 0137Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00802526531101), received between Nov 6, 2018 and Sep 30, 2026 — classified as 42 injuries, 17 malfunctions.

The most frequently reported specific device problem is “High impedance” (13 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Insufficient Device Problem Information

  It was reported that this brady lead was an attempted implant due to unknown product performance anomaly. A new lead with the same model was implanted. No adverse patient effects were reported. The lead was returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943680 ↗
• InjuryAug 21, 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 50368214 ↗
• InjuryAug 11, 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 Methicillin-resistant Staphylococcus aureus (MRSA) infection. There was no additional adverse patient effects reported. The RV lead was explanted.

  Patient problems: Bacterial Infection

  MAUDE report 50209667 ↗
• MalfunctionMay 18, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXHIBITING UNDERSENSING THAT LED TO INCREASED PACING ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. TECHNICAL SERVICES (TS) REVIEWED AND NOTED THE LEAD HAD LIKELY DISLODGED OR SLACK HAD PULLED ON THE LEAD. THE PATIENT WAS RECOMMENDED TO FOLLOW UP AT THE CLINIC. THIS ICD AND LEADS REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203983 ↗
• InjuryApr 6, 2026High impedance

  IT WAS REPORTED THAT DURING INITIAL IMPLANT TESTING, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NORMAL IMPEDANCE MEASUREMENTS AND THE POCKET WAS CLOSED. UPON RE-TESTING, THIS RV LEAD EXHIBITED OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE POCKET WAS THEN RE-OPENED, AND THE SCREW WAS LOOSENED AND RE-TIGHTENED. TECHNICAL SERVICES (TS) COULD NOT CONCLUSIVELY DETERMINE THE REASON FOR THE OUT-OF-RANGE MEASUREMENT AND SUGGESTED TESTING THE LEAD OR LEAD REPLACEMENT. TS ALSO RECOMMENDED FURTHER MONITORING. THE PATIENT WAS MONITORED AND PLANNED TO BE CHECKED THE FOLLOWING DAY; HOWEVER, THE ISSUE HAD RESOLVED ITSELF. THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792865 ↗
• InjuryMar 30, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD PACING AND SENSING WAS SURGICALLY ABANDONED. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24723095 ↗
• InjuryMar 24, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Failure to Read Input Signal; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) EXHIBITED LOW INTRINSIC AMPLITUDE AND AN INCREASE IN RV LEAD IMPEDANCE WITHIN NORMAL LIMITS. THE DEVICE, IMPLANTED A FEW MONTHS PRIOR, SHOWED STABLE R-WAVE MEASUREMENTS INITIALLY, FOLLOWED BY A SIGNIFICANT DECREASE IN AMPLITUDE AND A RISE IN IMPEDANCE. REVIEW OF DEVICE DATA ALSO NOTED NOISE ON THE SHOCK ELECTROGRAM AND OVERSENSING ON THE RV CHANNEL. THE HEALTH CARE PROFESSIONAL (HCP) SUSPECTED POSSIBLE LEAD DISLODGEMENT, AND TROUBLESHOOTING STEPS INCLUDING IMAGING AND FURTHER EVALUATION OF LEAD POSITION WERE RECOMMENDED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678395 ↗
• MalfunctionMar 13, 2026Signal Artifact/Noise; Low impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF ZERO OHMS. TECHNICAL SERVICES (TS) NOTED THERE WAS FINE NOISE WHICH APPEARED TO BE ELECTROMAGNETIC INTERFERENCE (EMI) ON THE ELECTROGRAM (EGM). TS WAS UNABLE TO CONCLUSIVELY DETERMINE THE SOURCE OF THE OUT OF RANGE MEASUREMENT. THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589396 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED ITCHING AT THE DEVICE SITE. IT WAS ALSO REPORTED THAT THE PATIENT HAS A KNOWN NICKEL ALLERGY. TECHNICAL SERVICES (TS) DISCUSSED THE DEVICE MATERIALS AND INDICATED THAT ONLY THE RIGHT VENTRICULAR (RV) LEAD CONTAINS COMPONENTS WITH DIRECT NICKEL CONTACT. TS RECOMMENDED TO CONTACT THE PHYSICIAN FOR EVALUATION OF THE REPORTED SYMPTOMS. AT THIS TIME, THIS RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 24148712 ↗
• InjuryDec 31, 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23931903 ↗
• InjurySep 23, 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 SURGICALLY ABANDONED DUE TO UNKNOWN CAUSE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS RV LEAD PACING AND SENSING PORTION WAS CAPPED AND STRICTLY USED AS SHOCKING OR DEFIBRILLATION LEAD. THIS LEAD FUNCTIONED PROPERLY WITH A GOOD OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23129884 ↗
• InjuryJun 30, 2025High impedance; Failure to Convert Rhythm; High impedance; Failure to Convert Rhythm

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) HAD AN EPISODE OF EIGHT SHOCKS WHERE SEVEN OF THEM DID NOT APPROPRIATELY CONVERT THE RHYTHM. IT WAS OBSERVED THAT THE SHOCK IMPEDANCES WERE HIGH WITHIN RANGE AND THAT THIS PATIENT EXHIBITED A CARDIAC ARREST. SUBSEQUENTLY, THIS PATIENT WAS BROUGHT IN FOR DEFIBRILLATION THRESHOLD (DFT) TESTS THAT WERE NOT SUCCESSFUL. MALPOSITION OF THE LEAD WAS SUSPECTED, AND THIS LEAD WAS ULTIMATELY EXPLANTED AND REPLACED WITH A LEAD IN MORE APICAL LOCATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Arrest

  MAUDE report 22366948 ↗
• InjuryMay 28, 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 WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22101750 ↗
• MalfunctionApr 23, 2025Signal Artifact/Noise; Failure to Capture; Failure to Read Input Signal; Data Problem; Signal Artifact/Noise; Failure to Capture; Failure to Read Input Signal; Data Problem

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING INTERMITTENT LOSS OF CAPTURE (LOC). FREQUENT PREMATURE VENTRICULAR CONTRACTION (PVC) CAUSED FUSION BEATS, AND AN ASYSTOLE WAS INAPPROPRIATELY SEEN BY THE DEVICE. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891364 ↗
• InjuryFeb 24, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Low impedance; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Low impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. IN ADDITION, OVERSENSING OF MYOPOTENTIAL NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL WAS NOTED. TECHNICAL SERVICES (TS) WAS CONSULTED, AND IT WAS RECOMMENDED TO REPLACE THE SYSTEM. SUBSEQUENTLY, THIS CRT-D SYSTEM WAS EXPLANTED AND REPLACED. OTHER THAN ASYSTOLE FOR 2.5 SECONDS, PACING INHIBITION AND THE PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS RV LEAD WAS ALREADY RETURNED TO BOSTON SCIENTIFIC.

  Patient problems: Asystole

  MAUDE report 21454732 ↗
• MalfunctionJan 28, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A UNDERSENSE BEAT. TECHNICAL SERVICES (TS) WAS CONSULTED AND EXPLAINED THE DETECTION IS NO DELAYED. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21254028 ↗
• InjuryNov 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 THE SYSTEM REVISION DUE TO BACTEREMIA. REPORTEDLY, THE PATIENT HAD INFLAMMATION, EDEMA, AND SWELLING. THE PATIENT ALSO HAD NIGHT SWEATS AND A HIGH FEVER. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Bacterial Infection; Fever; Inflammation; Swelling/ Edema

  MAUDE report 20646551 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF A SYSTEM REVISION DUE TO BACTEREMIA. REPORTEDLY, THE PATIENT PRESENTED TO THE HOSPITAL WITH A PAINFUL POCKET, SWELLING, AND DISCOMFORT. THE PHYSICIAN STARTED WITH ANTIBIOTICS, SENT SAMPLES FOR BLOOD CULTURE AND DISCHARGE THE PATIENT. BLOOD CULTURES CAME BACK POSITIVE FOR STAPHYLOCOCCUS BACTEREMIA. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD WAS EXPLANTED.

  Patient problems: Bacterial Infection; Discomfort; Pain; Swelling/ Edema

  MAUDE report 20626915 ↗
• InjurySep 15, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO NOISE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20221118 ↗
• InjuryApr 2, 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 INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 19018103 ↗
• InjuryJan 31, 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 18619536 ↗
• InjuryDec 12, 2023Signal Artifact/Noise; Off-Label Use; Signal Artifact/Noise; Off-Label Use

  IT WAS REPORTED THAT DURING THE SYSTEM CHANGE PROCEDURE, THE PHYSICIAN OPTED TO PLACE THIS RIGHT VENTRICULAR (RV) LEAD OUTSIDE OF THE HEART. THE RV LEAD TIP WAS CAPPED AND SEWN DOWN; HOWEVER NOISY SIGNALS WERE SEEN THROUGH THE NEW IMPLANTED DEVICE. TECHNICAL SERVICES (TS) STATED THAT IF THE RV WAS TO BE SEWN ON THE OUTSIDE OF THE HEART IT WILL NOT BE GOING TO SENSE VENTRICULAR FIBRILLATION (VF) APPROPRIATELY. IT WAS AT PHYSICIAN'S DISCRETION TO PROCEED. THIS RV REMAINS IN SERVICE. NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18314159 ↗
• InjuryJul 6, 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 POCKET EROSION AND INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD REMAINS IN SERVICE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 17269360 ↗
• InjuryJun 22, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLDS. FLUOROSCOPY IMAGING WAS PERFORMED, AND IT WAS DISCOVERED THAT THE LEAD POSITION WAS THE CAUSE OF THE HIGH PACING THRESHOLDS. THE RV LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD IS EXPECTED TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17185690 ↗
• InjuryMay 8, 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 A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16891855 ↗

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,