Skip to content

ENDOTAK RELIANCE® SG 0171Recalls & reported problems

Boston Scientific Corporation · Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead · Class 3 · Implant

All models of ENDOTAK RELIANCE SG (9)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Endotak Reliance SG implantable defibrillator lead is named in 40 adverse event reports, mostly describing high shock impedance, sometimes with gradual increases tied to coil calcification, along with lead replacements or fractures. There are no deaths and 26 injuries. One open recall started July 2025 because affected leads may experience gradually rising LVSI measurements with calcified defibrillation coils, which may lead to early lead replacement, with most serious harm cited as death or cardiac resuscitation.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
41
Deaths reported
0
Injuries reported
26
Recalls naming it
1

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00802526373374), received between Jul 12, 2016 and Jul 29, 2026 — classified as 26 injuries, 15 malfunctions.

The most frequently reported specific device problem is “High impedance” (29 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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 2 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 2 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 2 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Jul 24, 2025Open, 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-2325-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Device problems

  • High impedance29
  • High Capture Threshold7
  • Defective Device5
  • Fracture5
  • Over-Sensing5
  • Signal Artifact/Noise4
  • Adverse Event Without Identified Device or Use Problem3
  • Device Sensing Problem2

Patient problems

  • No Clinical Signs, Symptoms or Conditions23
  • No Known Impact Or Consequence To Patient7
  • No Consequences Or Impact To Patient4
  • Unspecified Infection3
  • Insufficient Information2
  • No Code Available2
  • Calcium Deposits/Calcification1
  • Complaint, Ill-Defined1

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 29, 2026High impedance

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50077206 ↗
  • InjuryJul 3, 2026Signal Artifact/Noise; Fracture; High impedance; Failure to Read Input Signal

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN OUT OF RANGE INTRINSIC AMPLITUDE OUTPUTS OF 5.7 MILLIVOLTS TO 23.8 MILLIVOLTS. THE PATIENT WAS SEEN IN THE OFFICE BUT WAS NOT ABLE TO REPRODUCE THE ANOMALY. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT NOTED THAT ALL OTHER LEAD MEASUREMENTS WERE NORMAL. AS OF THIS TIME, THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE INVOLVED RIGHT ATRIAL LEAD EXHIBITED NON-PHYSIOLOGICAL SIGNALS AND LARGE SIGNAL ARTIFACTS ACROSS ALL THREE ELECTROGRAM CHANNELS. THESE SIGNALS ORIGINATED ON THE RIGHT ATRIAL LEAD, WITH SOME APPEARING TO CONDUCT TO THE RIGHT VENTRICULAR LEAD FOLLOWING THE PLACEMENT OF A HEMODIALYSIS CATHETER. THE TS CONSULTANT RECOMMENDED PERFORMING A CHEST X-RAY TO SEND TO TS AND REVIEW WHETHER THE CATHETER IS DANGLING INTO THE RIGHT ATRIUM. FURTHERMORE, THE DIALYSIS CATHETER WAS OBSERVED TO BE POSITIONED AGAINST THE CARDIAC LEADS IN THE DEVICE POCKET, RAISING CONCERN FOR A POSSIBLE LEAD FRACTURE. THIS ISSUE RESULTED IN AN OUT-OF-RANGE SHOCK LEAD IMPEDANCE ALERT AND LOGGED EPISODES OF NON-SUSTAINED VENTRICULAR ARRHYTHMIA. TS NOTED THAT THESE EPI

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25707112 ↗
  • InjuryFeb 11, 2026High impedance; Failure to Convert Rhythm

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH WITHIN RANGE SHOCK IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) RECOMMENDED FURTHER MONITORING OF THIS LEAD. SUBSEQUENTLY, THIS LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24318700 ↗
  • InjuryJan 27, 2026High impedance

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN SHOCK IMPEDANCES. A REVISION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, THE PHYSICIAN NOTED THE RV LEAD HAD CALCIFIED. THE RV LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Calcium Deposits/Calcification

    MAUDE report 24189276 ↗
  • InjuryOct 15, 2025Defibrillation/Stimulation Problem; Low impedance; Defective Device; Defibrillation/Stimulation Problem; Low impedance; Defective Device

    IT WAS REPORTED THAT THE PATIENT WITH A NON-BOSTON SCIENTIFIC DEVICE AND THIS RIGHT VENTRICULAR (RV) LEAD, HAD A VENTRICULAR TACHYCARDIA (VT) EPISODE. A SHOCK WAS DELIVERED BUT THERE WAS NOT ENOUGH ENERGY TO REVERT THE RHYTHM AS THE SHOCK IMPEDANCE MEASUREMENTS WERE LOW OUT OF RANGE AT THAT MOMENT. PATIENT HAD TO BE EXTERNALLY RESCUED. THE PATIENT HAD A SECOND VENTRICULAR TACHYCARDIA (VT) EPISODE, AND AN APPROPRIATE ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED WHICH CONVERTED THE ARRHYTHMIA. TECHNICAL SERVICES (TS) SUSPECTED POSSIBLE LEAD DAMAGE AND CALCIFICATION. A LEAD REPLACEMENT WAS RECOMMENDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION INDICATED THAT THERE WAS A CLEAR INSULATION BREACH. AS A RESULT, THIS LEAD WAS EXPLANTED AND REPLACED WITH A NONE BOSTON SCIENTIFIC LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD HAS NOT BEEN RETURNED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23306110 ↗
  • MalfunctionAug 7, 2025High impedance; High impedance

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD RECORDED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) REVIEWED THE LEAD DATA AND NOTED THAT THE LEAD TREND WAS AROUND 100 OHMS. TS DISCUSSED THE ADVISORY AND PROVIDED REPROGRAMMING RECOMMENDATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22740237 ↗
  • 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 22644161 ↗
  • InjuryFeb 19, 2025Defective Device; Defective Device

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

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21412653 ↗
  • InjuryFeb 12, 2025Fracture; Defective Device; Fracture; Defective Device

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS SUSPECTED OF LEAD FRACTURE, PER LEAD TESTING. HOWEVER, THE LOCATION OF THE LEAD FRACTURE WAS NOT DETERMINED. SUBSEQUENTLY, THIS RV LEAD WAS EXPLANTED, REPLACED, AND RETURNED FOR ANALYSIS. IT WAS NOTED THAT THE CRT-D WAS ALSO EXPLANTED AND REPLACED, WITH NO REPORTED ALLEGATIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21361559 ↗
  • InjuryNov 16, 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 20701305 ↗
  • MalfunctionOct 18, 2024High impedance; High impedance

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES MEASURING ABOVE 200 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20488653 ↗
  • InjuryFeb 19, 2024High impedance; No Apparent Adverse Event; High impedance; No Apparent Adverse Event

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO A NON-SPECIFIC PRODUCT PERFORMANCE ANOMALY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18735951 ↗
  • MalfunctionJan 31, 2024High impedance; High Capture Threshold; High impedance; High Capture Threshold

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS, MEASURING GREATER THAN 3000 OHMS. THE DEVICE EXHIBITED AN ALERT DUE TO OUT-OF-RANGE IMPEDANCES SINCE A YEAR NOW. UPON REVIEW, THERE THRESHOLD VALUES WERE SLIGHTLY HIGH WHEN THE PATIENT WAS SEEN IN CLINIC IN 2022. TECHNICAL SERVICES (TS) RECOMMENDED TO HAVE PATIENT SEEN IN CLINIC FOR FURTHER EVALUATION AS THERE WAS A GRADUAL INCREASE IN THE IMPEDANCE VALUE. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18613708 ↗
  • InjuryJan 5, 2024Fracture; Fracture

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) WAS FRACTURED. THIS LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18460970 ↗
  • InjuryAug 8, 2023Fracture; High impedance; High Capture Threshold; Fracture; High impedance; High Capture Threshold

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO A HIGH IMPEDANCE AND ELEVATED THRESHOLDS. A LEAD FRACTURE WAS SUSPECTED; HOWEVER, THE FRACTURE COULD NOT BE CONFIRMED VIA FLUOROSCOPY. ADDITIONAL INFORMATION RECEIVED WHICH INDICATED THAT THIS LEAD WAS FRACTURED. THIS LEAD WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17481780 ↗
  • InjuryApr 5, 2023High impedance; High impedance

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED BOTH HIGH OUT OF RANG PACING AND SHOCKING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS AND 125 OHMS, RESPECTIVELY. SURGICAL INTERVENTION WAS PERFORMED AND THE RV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16685881 ↗
  • InjuryFeb 21, 2023Signal Artifact/Noise; High impedance; Material Integrity Problem; Signal Artifact/Noise; High impedance; Material Integrity Problem

    IT WAS REPORTED DURING A ROUTINE DEVICE REVISION PROCEDURE, THAT THIS RIGHT VENTRICULAR RV LEAD WAS SURGICALLY CAPPED/ABANDONED (I.E., IT REMAINS IMPLANTED, BUT IS NO LONGER IN SERVICE) AFTER EXHIBITING HIGH, OUT OF RANGE SHOCK IMPEDANCE (GREATER THAN 200 OHMS) AND NOISE. THE PHYSICIAN DETERMINED THERE TO BE A LEAD MECHANICAL ISSUE AT THE TERMINAL PIN. A NEW LEAD WAS IMPLANTED. BESIDES SURGICAL INTERVENTION, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16408734 ↗
  • MalfunctionFeb 20, 2023High impedance; High impedance

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED GRADUAL INCREASING SHOCK IMPEDANCES WITH CURRENT MEASUREMENTS > 125 OHMS. THE ASSOCIATED DEVICE WAS REPLACED FOR NORMAL BATTERY DEPLETION AND DURING THIS ROUTINE INTERVENTION, SHOCK LEAD IMPEDANCE TESTING WAS PERFORMED. THE IMPEDANCES ARE STILL GREATER THAN 125; HOWEVER, THE PHYSICIAN ELECTED TO KEEP THE RV LEAD IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16401626 ↗
  • InjuryJan 31, 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 16274153 ↗
  • InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INFECTION WITH SEPSIS WAS PART OF THE SYSTEM REVISION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

    Patient problems: Sepsis; Unspecified Infection

    MAUDE report 14138653 ↗
  • MalfunctionApr 6, 2022High impedance; High Capture Threshold; High impedance; High Capture Threshold

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED THRESHOLDS AND HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE PACING IMPEDANCE MEASUREMENTS WERE ALSO NOTED TO HAVE INCREASED, HOWEVER REMAINED WITHIN NORMAL LIMITS. PROVOCATIVE MANEUVERS WERE PERFORMED WITH NO OVERSENSING NOTED. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING OPTIONS AND RECOMMENDED PERFORMING A COMMANDED SHOCK. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14032299 ↗
  • InjuryJan 2, 2022High impedance; High impedance

    IT WAS REPORTED THAT THIS RIGHT VENTRICLE (RV) LEAD EXHIBITED HIGH, OUT OF RANGE SHOCK IMPEDANCE OF GREAT THAN 200 OHMS. THE PHYSICIAN REPORTED THE SHOCK IMPEDANCES TO BE CONSISTENTLY HIGH. ALL OTHER MEASUREMENTS ARE WITHIN NORMAL RANGE. THE PHYSICIAN WILL MONITOR THE PATIENT CLOSELY. THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NEW INFORMATION WAS RECEIVED DURING A FOLLOW UP APPOINTMENT, LEAD INTEGRITY TESTING , AT 1,1 J AND SHOCK IMPEDANCE WAS >125OHM. THE PHYSICIAN SCHEDULED THE PATIENT FOR A LEAD REVISION PROCEDURE THE NEXT DAY. NEW INFORMATION WAS RECEIVED THAT THIS RV LEAD WAS EXPLANTED, AND NEW ONE IMPLANTED. X-RAY IMAGES CONFIRMED NO LEAD FRACTURES. BESIDES SURGICAL INTERVENTION, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13138627 ↗
  • MalfunctionOct 17, 2021High impedance; High impedance

    IT WAS REPORTED THAT THE REMOTE HOME MONITOR ISSUED AN ALERT FOR HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS FOR THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE RV LEAD HAS EXHIBITED VARIABLE IMPEDANCE MEASUREMENTS BETWEEN 1600 OHMS AND 2000 OHMS FOR MORE THAN ONE YEAR. THE PATIENT WAS BROUGHT IN FOR A FOLLOW-UP WHERE PROVOCATIVE MANEUVERS WERE PERFORMED AND NO EPISODES OF NOISE OR SUDDEN CHANGES OF THE PACING IMPEDANCE MEASUREMENTS WERE RECORDED. DURING THE OFFICE VISIT THE RV LEAD IMPEDANCE MEASUREMENT WAS STABLE AROUND 1800 OHMS. THE CLINIC WILL CONTINUE TO PERFORM REMOTE INTERROGATIONS WITH AMBULATORY FOLLOW UPS EVERY SIX MONTHS. THE RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12644129 ↗
  • InjuryJul 23, 2021Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

    IT WAS REPORTED THAT DURING A TROUBLESHOOTING, NOISY SIGNALS WERE OVERSENSED IN THE RIGHT VENTRICULAR (RV) CHANNEL. PECTORAL MYOPOTENTIALS MANEUVERS WERE POSITIVE, AS A RESULT, THE PHYSICIAN DECIDED TO ADJUST THE SENSITIVITY AND TO CONTINUE TO MONITOR THE PATIENT VIA LATITUDE MONITOR SYSTEM. NO REPORTED ASYSTOLE. AT THIS TIME, THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION CONFIRMED THAT ON APRIL 6TH, PROVOCATIVE MANEUVERS WERE PERFORMED AND PECTORAL MYOPOTENTIALS REPRODUCED AND MARKED AS VT. THE PHYSICIAN DECIDED TO EXTRACT THE LEAD SOON IN ANOTHER HOSPITAL. BOSTON SCIENTIFIC TECHNICAL SERVICES BOSTON SCIENTIFIC TECHNICAL ANALYZED THE DATA AND CONCLUDE THAT THERE ARE TOW SETS OF NOISE, ONE COULD BE DUE TO THE RV TO CAN VECTOR FOR THE HV EGM AND THE OTHER SIGNAL IS VERY REGULAR AND CYCLIC IN NATURE USUALLY INDICATIVE OF SOME SORT OF EMI. ON MAY 12TH, THE LEAD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 12221258 ↗
  • InjuryJun 23, 2021High impedance; Over-Sensing; High Capture Threshold; High impedance; Over-Sensing; High Capture Threshold

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) PACE IMPEDANCE WAS OUT OF RANGE AT 2,267 OHMS. THE IMPEDANCE HAD BEEN GRADUALLY RISING AND WAS GREATER THAN 2,000 OHMS ON MULTIPLE OCCASIONS. ALL OTHER LEAD MEASUREMENTS WERE AS EXPECTED. TECHNICAL SERVICES (TS) RECOMMENDED INCREASING THE IMPEDANCE ALERT ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR TO 2,500 OHMS. ADDITIONALLY REPORTED THAT THE RV CAPTURE THRESHOLD WAS ALSO INCREASING. SHOCK IMPEDANCE WAS STABLE, SENSING WAS GOOD AND NO SIGNAL NOISE WAS NOTED. TS RECOMMENDED FURTHER TROUBLESHOOTING IN CLINIC. ANOTHER ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THIS RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 12054979 ↗

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-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,

Other Implantable cardioverter defibrillator (non-CRT) devices

All Implantable cardioverter defibrillator (non-CRT) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page