ENDOTAK RELIANCE® 0148Recalls & reported problems

Summary

The FDA's MAUDE database contains 223 adverse event reports that list this exact device (DI 00802526085918), received between Feb 10, 2009 and Sep 25, 2026 — classified as 2 deaths, 163 injuries, 58 malfunctions.

The most frequently reported specific device problem is “High impedance” (88 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 223 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50902892 ↗
• MalfunctionSep 22, 2026High impedance

  Boston Scientific CRM received information that this Right Ventricular (RV) defibrillation lead exhibited high pace impedance >2000 ohms. Impedance had been rising from approximately 1800 ohms in November to >2000 ohms now. No adverse patient effects have been reported. Additional information indicated that the lead continues to have high pacing impedance measurements. The physician is aware of these measurements and has decided to monitor the patient at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862154 ↗
• MalfunctionAug 7, 2026High impedance

  It was reported that this right ventricular (RV) lead triggered an alert for high, out of range shock impedance values. After a vector breakdown a proximal coil issue was identified. Technical Services (TS) mentioned that if the plan was to reprogram for changing shocking vectors, then a defibrillation threshold (DFT) test should be completed.Additional information from the field was received mentioning that the origin for the high, out of range shock impedance was confirmed to be an issue at the proximal coil by doing a vector breakdown. Also, the lead was reprogramed distal coil to device, and a defibrillation threshold test was completed. The RV lead remains in service at this time. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50169672 ↗
• MalfunctionJul 27, 2026Signal Artifact/Noise; Over-Sensing; Low impedance

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008149 ↗
• MalfunctionMay 15, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE WHICH WAS OVERSENSED. TECHNICAL SERVICES (TS) SUSPECTED THE NOISE WAS ELECTROMAGNETIC INTERFERENCE (EMI). IT WAS ALSO REPORTED THIS RV LEAD EXHIBITED A GRADUAL RISE OF PACING IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT THE PACING IMPEDANCE MEASUREMENTS WERE WITHIN RANGE. TS RECOMMENDED CONTINUED MONITORING. THIS RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186118 ↗
• InjurySep 15, 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 23054349 ↗
• InjuryAug 4, 2025Fracture; High impedance; High Capture Threshold; Fracture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED TO BE FRACTURED DUE TO SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS AND CHRONIC HIGH THRESHOLDS. A REVISION PROCEDURE WILL BE PERFORMED IN THE NEAR FUTURE TO REPLACE THE LEAD. THE LEAD REMAINS IN SERVICE AT THIS TIME AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS REPORTED THAT THIS LEAD WAS SUBSEQUENTLY REMOVED FROM SERVICE AND SURGICALLY ABANDONED. A REPLACEMENT BOSTON SCIENTIFIC LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701000 ↗
• InjuryAug 4, 2025Fracture; High impedance; Defibrillation/Stimulation Problem; Fracture; High impedance; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE, GREATER THAN 200 OHMS, AND THERE WERE NO THRESHOLD MEASUREMENTS WHEN CONNECTED TO THE ICD. THIS OCCURRED DURING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANT PROCEDURE. THE PHYSICIAN CHECKED THE LEADS WERE IN THE CORRECT PORTS AND REINSERTED INTO THE HEADER. A SHOCK WAS ATTEMPTED AND THIS RV LEAD EXHIBITED CODE 1005, INDICATIVE OF AN OPEN CIRCUIT CONDITION DURING SHOCK DELIVERY. THE SHOCK ELECTROGRAM (EGM) WAS FLAT. IT WAS SUSPECTED THAT THE DISTAL COIL CONDUCTOR WAS BROKEN WHEN THE PHYSICIAN MANIPULATED THE CONNECTIONS. 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 22699363 ↗
• InjuryMay 1, 2025Signal Artifact/Noise; Fracture; Impedance Problem; Signal Artifact/Noise; Fracture; Impedance Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO A FRACTURE, NOISY SIGNALS, AND IMPEDANCE ISSUES. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED WITH ANOTHER ICD DUE TO A THERAPY UPGRADE. ANOTHER RV LEAD WAS USED AS A REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21946615 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS TACHY LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN REASON. A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941569 ↗
• InjuryApr 17, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. NO OTHER INFORMATION WAS PROVIDED. THIS RV LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859784 ↗
• MalfunctionApr 17, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857297 ↗
• InjuryJan 10, 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 21123699 ↗
• InjurySep 12, 2024Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; High Capture Threshold; Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE ON THE PACE/SENSE AND SHOCK CHANNEL. THE NOISE WAS OVERSENSED WHICH RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) TO BE DELIVERED. IT WAS ALSO NOTED THAT THE RV PACING IMPEDANCE AND THRESHOLD MEASUREMENTS INTERMITTENTLY INCREASED. SUBSEQUENTLY, THIS RV LEAD WAS CAPPED AND REPLACED. OTHER THAN THE SURGICAL PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207152 ↗
• InjuryAug 28, 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 20092152 ↗
• InjuryAug 27, 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. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20080854 ↗
• MalfunctionAug 26, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STATED THAT THEIR REMOTE COMMUNICATOR DISPLAYED A RED CALL DOCTOR ICON. SUBSEQUENTLY, LATITUDE DATA WAS REVIEWED AND IT WAS DETERMINED THAT THIS ICD WAS EXHIBITING HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD SYSTEM REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20072416 ↗
• MalfunctionAug 22, 2024Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Defective Device; High Capture Threshold; Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Defective Device; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD OVERSENSED NOISE WHICH RESULTED IN AN INAPPROPRIATE SHOCK AND ANTI-TACHYCARDIA PACING (ATP). NO ASYSTOLE EPISODE WAS NOTED. DATA WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR THEIR REVIEW. A FOLLOW UP WAS SCHEDULE TO PERFORM MANEUVERS. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. DATA WAS ANALYZED BY TS AND IT WAS CONCLUDED THE NOISE OBSERVED IS ON BOTH PACE/SENSE AND HV ELECTROGRAM (EGM) . NORMALLY, NOISE ON BOTH IS AN INDICATION OF SOME EMI ADDITIONAL INFORMATION PROVIDED BY SALES REPRESENTATIVE CONFIRMED THIS IS A ONLY LEAD ISSUE. DURING FOLLOW UP, NO CHANGES WERE MADE. ADDITIONAL INFORMATION WAS RECEIVED DETAILING THAT THIS LEAD CONTINUED TO PRESENT THIS NOISE EVEN AFTER THE DEVICE WAS EXPLANTED AND REPLACE DUE TO NORMAL BATTERY DEPLETION. ADDITIONALLY, HIGH PACING THRESHOLDS AND HIGH WITHING RANGE PACING AND SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED. LEAD DAMAGE IS BEING SUSPECTED, HOWEVER AT THIS TIME, IT HAS NOT BEEN CONFIRMED. REPLACEMENT OF THE LEAD WAS RECOMMENDED. AT THIS TIME, THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20039325 ↗
• InjuryAug 22, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO NON-SPECIFIC PRODUCT PERFORMANCE ISSUE. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028338 ↗
• InjuryJul 23, 2024Signal Artifact/Noise; Fracture; High impedance; High Capture Threshold; Signal Artifact/Noise; Fracture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR PACING LEAD IMPEDANCE, HIGH, OUT OF RANGE. HISTORY SHOWS GRADUAL RISE IN IMPEDANCE. THERE WAS NOISE ON STORED EVENTS IN THE PAST, THAT CORRESPOND TO A SURGICAL PROCEDURE. PROGRAMMING OPTIONS WERE DISCUSSED FOR THIS RV LEAD. ADDITIONAL INFORMATION WAS RECEIVED MENTIONING THAT RV PACING THRESHOLDS WERE ON THE HIGHER END AS WELL AND THE PHYSICIAN ELECTED TO REPLACE THE LEAD WITH THE PATIENT BEING PACEMAKER DEPENDENT, THEREFORE IT WAS SURGICALLY ABANDONED. A LEAD FRACTURE WAS ASSUMED. THE RV LEAD IS NOT EXPECTED TO BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19803062 ↗
• InjuryJul 17, 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 INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 19767173 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT A WIRE WAS STICKING OUT OF THEIR BODY AND THEY USED A BAND AID TO COVER IT UP AND KEEP IT IN PLACE. AFTER A REPLACEMENT PROCEDURE FOR THEIR LAST DEVICE, THE WIRE WAS NO LONGER STICKING OUT OF THEIR BODY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 19664739 ↗
• InjuryJun 18, 2024Fracture; High impedance; High Capture Threshold; Fracture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AS WELL AS HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS THAT WERE OVER 2000 OHMS. FLUOROSCOPY CONFIRMED THAT THIS WAS CAUSED BY A SUBCLAVIAN CRUSH WHICH FRACTURED THE LEAD. THIS LEAD WAS EXPLANTED AND REPLACED WITH A NEW RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT HAS BEEN RETAINED BY THE USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558732 ↗
• InjuryApr 24, 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 BACTERIAL INFECTION IN HEART AND LOWER SPINE FROM A TOOTH INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE RV LEAD REMAINS IN SERVICE.

  Patient problems: Bacterial Infection

  MAUDE report 19177676 ↗
• InjuryApr 11, 2024Signal Artifact/Noise; Fracture; Impedance Problem; Signal Artifact/Noise; Fracture; Impedance Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED POOR IMPEDANCE TRENDS AND JUMPS IN IMPEDANCE LEADING TO SUSPICION OF LEAD FRACTURE. DURING THE EXTRACTION PROCEDURE THE SUPERIOR VENA CAVA WAS TORN, AND A PROCEDURE WAS PERFORMED TO REPAIR IT. THIS LEAD WAS SURGICALLY ABANDONED, AND THE REPLACEMENT PROCEDURE WAS POSTPONED. SUBSEQUENTLY A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANT PROCEDURE WAS SUCCESSFULLY PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Perforation of Vessels

  MAUDE report 19088797 ↗

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,
• 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