ENDOTAK RELIANCE® G 0285Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00802526431401), received between Apr 21, 2016 and Sep 25, 2026 — classified as 1 death, 64 injuries, 27 malfunctions.

The most frequently reported specific device problem is “High impedance” (40 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 18, 2026.

Recalls naming this device

1. Jul 24, 2025Class IOpen, 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-2326-2025 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902958 ↗
• MalfunctionMay 29, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD SHOWED EPISODE WITH A POTENTIAL NON-PHYSIOLOGIC SIGNAL. TECHNICAL SERVICES (TS) NOTED THAT THE ALERT WAS DUE TO TWO NOISY SUSTAINED NO-THERAPY EPISODES WITHIN THE PAST 24 HOURS. ATTEMPT INFORMATION INDICATES THAT DEVICE THERAPY WAS OFF, WHICH MAY SUGGEST MAGNET PRESENCE OVER THE DEVICE. THE SIGNALS APPEAR CONSISTENT WITH NON-PHYSIOLOGIC ACTIVITY, SUCH AS ELECTROMAGNETIC INTERFERENCE (EMI) OVERSENSING. ALL LEAD MEASUREMENTS ARE WITHIN NORMAL LIMITS, AND THE CURRENT PRESENTATION APPEARS APPROPRIATE WITH INTRINSIC ACTIVITY PRESENT. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326514 ↗
• InjuryMay 28, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. ANOTHER RV LEAD WAS IMPLANTED TO COMPLETE THIS PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED AT THIS TIME. THE RV LEAD HAS NOT BEEN RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318021 ↗
• MalfunctionFeb 26, 2026High impedance

  IT WAS REPORTED THAT BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED BY THE PHYSICIAN TO EVALUATE THE SHOCK IMPEDANCE MEASUREMENTS OF NINE OF HIS PATIENTS INVOLVED IN THE RELIANCE EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) POTENTIAL CALCIFICATION/GRADUALLY RISING LOW-VOLTAGE SHOCK IMPEDANCE (LVSI) FIELD SAFETY NOTICE. THIS RIGHT VENTRICULAR (RV) LEAD IMPEDANCE HAS BEEN GRADUALLY INCREASING SINCE 2024 BUT STILL REMAINED IN-RANGE (UNDER 90 OHMS). THE PHYSICIAN IS CONTINUING WITH MONITORING. AT THIS TIME, THIS RV LEAD REMAINS IMPLANTED AND IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465012 ↗
• InjuryJan 16, 2026Fracture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE AND HIGH PACING THRESHOLD OUTPUTS DUE TO LEAD FRACTURE OR BREAKAGE. THIS RV LEAD WAS EXPLANTED, REPLACED WITH A DIFFERENT MODEL AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THE LEAD FRACTURE WAS CONFIRMED THROUGH FLUOROSCOPY AND DEVICE-BASED TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24104817 ↗
• MalfunctionNov 19, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING NOISE. THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR FURTHER REVIEW OF THE PRESENTING ELECTROGRAM (EGM). UPON REVIEW, THE PRESENTING EGM SHOWED THERE TO BE OVERSENSING NOISE ON THE RV LEAD. TS ALSO REVIEWED THE DAILY THRESHOLD AND IMPEDANCE MEASUREMENTS TREND AND NOTED THERE TO BE A STEEP RISE IN THE RV LEAD PACING IMPEDANCES FROM 850 OHMS TO 1183 OHMS AND A GRADUAL INCREASE IN SHOCK IMPEDANCES FROM 50 OHMS TO 110 OHMS. THE PACING AND SHOCK IMPEDANCES WERE DETERMINED TO BE WITHIN NORMAL LIMITS (WNL). TS DISCUSSED POSSIBLE CAUSES AND PROVIDED THE RV LEAD TO BE EXTRACTED. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600280 ↗
• MalfunctionAug 7, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS DUAL COIL DEFIBRILLATION LEAD EXHIBITED A GRADUAL INCREASE IN SHOCK IMPEDANCE MEASUREMENTS OVER THE PAST YEAR REACHING OUT OF RANGE. TECHNICAL SERVICES DISCUSSED THIS GRADUAL INCREASE IN MEASUREMENTS IS CONSISTENT WITH A PHYSIOLOGICAL CHANGE SUCH AS CALCIFICATION ON THE LEAD AND SUGGESTED INCREASING THE ALERT THRESHOLD TO 150 OHMS. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739052 ↗
• 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 22646867 ↗
• InjuryJul 29, 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. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED. IT IS UNKNOWN IF THIS RV LEAD WILL BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641832 ↗
• InjuryMar 19, 2025Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS THAT WERE GREATER THAN 2500 OHMS AND LOSS OF CAPTURE (LOC). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644366 ↗
• MalfunctionFeb 4, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. ATRIAL NOISE AND OVERSENSING WERE ALSO OBSERVED, LEADING TO INAPPROPRIATE ATRIAL TACHYCARDIA RESPONSE (ATR), WHICH WAS BELIEVED TO BE CAUSED BY ELECTROMAGNETIC INTERFERENCE (EMI). IN ADDITION, THERE WERE EPISODES OF PACEMAKER-MEDIATED TACHYCARDIA (PMT). CURRENTLY, THIS CRT-D SYSTEM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS ARE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308354 ↗
• InjuryDec 30, 2024Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED AN EPISODE OF INAPPROPRIATE SHOCKS DUE TO THE T-WAVE OVERSENSING. NO OTHER INFORMATION WAS PROVIDED. THIS LEAD WAS EXPLANTED THREE YEARS AFTER IMPLANT. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 21044951 ↗
• InjuryAug 15, 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 WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 19996489 ↗
• MalfunctionJul 23, 2024Failure to Capture; Unexpected Therapeutic Results; High Capture Threshold; Failure to Capture; Unexpected Therapeutic Results; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD DELIVERED ANTI-TACHYCARDIA PACING (ATP). TECHNICAL SERVICES (TS) WAS CONSULTED AND EXPLAIN THE ATP DIDN'T APPEAR TO HAVE CAPTURED WHEN DELIVERED AND THE THRESHOLD HAD RISEN. THE RV LEAD REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806503 ↗
• InjuryJul 3, 2024High impedance; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; High impedance; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A CLINIC VISIT, THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) WITH CONCERNS ABOUT THE PATIENT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM MAY HAVE RECEIVED INAPPROPRIATE A BURST OF ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY. THE HCP NOTED THAT DEVICE INTERROGATION REVEALED A CODE 1005, INDICATING AN OPEN CIRCUIT CONDITION. TS REVIEWED THE STORED DATA AND CONFIRMED THAT PATIENT RECEIVED INAPPROPRIATE BURST OF ATP AND SHOCK THERAPY DUE TO ATRIAL DRIVEN ARRHYTHMIA. THE SHOCK THERAPY WAS ABLE TO CONVERT THE ARRYTHMIA. TS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHOCK IMPEDANCES GREATER THAN 125 OHMS WHICH LED TO THE CODE 1005 THEN SHOCK WAS BEING DELIVERED. TS DISCUSSED WITH THE HCP AND RECOMMENDED FOR THE RV LEAD TO BE REPLACED. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THAT A REVISION PROCEDURE WAS PERFORMED, THE RV LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19667927 ↗
• MalfunctionMay 23, 2024High impedance; High impedance

  IT WAS REPORTED THAT DURING A CLINIC VISIT, THIS RIGHT VENTRICULAR (RV) LEAD WAS OBSERVED TO EXHIBIT HIGH OUT OF RANGE SHOCK IMPEDANCES MEASURING GREATER THAN 125 OHMS. THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) AND REQUESTED LEAD EVALUATION. TS REVIEWED THE PRESENTING IMPEDANCE TRENDS AND CONFIRMED THE HIGH OUT OF RANGE IMPEDANCES. TS DISCUSSED POSSIBLE CAUSES AND RECOMMENDED FOR A COMMANDED SHOCK FOR FURTHER EVALUATION OF THE LEAD INTEGRITY. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387895 ↗
• InjuryMay 14, 2024High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASING THRESHOLDS AND DECREASING PACE IMPEDANCE FROM 1400 TO 820 OHMS. THE PHYSICIAN HAD DECIDED TO CHANGE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR THERAPY PURPOSES AND SUBSEQUENTLY DECIDED TO EXPLANT AND REPLACE THE RV LEAD AS WELL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315977 ↗
• InjuryAug 3, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS OVERSENSING R WAVES. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17449344 ↗
• InjuryJul 19, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD. THE LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352159 ↗
• InjuryJun 26, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS SINCE MAY 2019. TECHNICAL SERVICES (TS) REVIEWED POSSIBLE CAUSES AND RECOMMENDED A VECTOR BREAKDOWN. VECTOR BREAKDOWN REVEALED RIGHT ATRIAL (RA) COIL TO CAN WAS IN THE 80 OHMS RANGE, RV TO CAN WAS >200 OHMS, AND RV TO RA WAS >200 OHMS. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DURING A DEVICE UPGRADE PROCEDURE FROM AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17205851 ↗
• InjuryMay 19, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH THRESHOLD. ADDITIONAL INFORMATION WAS OBTAINED WHICH INDICATED THAT THE CAUSE FOR HIGH THRESHOLD WAS DUE TO PATIENT CONDITION. THE LEAD WAS SURGICALLY ABANDONED, AND A NEW LEAD WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16968046 ↗
• InjuryMay 19, 2023No Apparent Adverse Event; High Capture Threshold; No Apparent Adverse Event; High Capture Threshold

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962607 ↗
• InjuryMar 10, 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 16521525 ↗
• InjuryMar 2, 2023High impedance; No Apparent Adverse Event; High Capture Threshold; High impedance; No Apparent Adverse Event; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH CAPTURE THRESHOLD AND HIGH SHOCK IMPEDANCE MEASUREMENTS. SUCCESSFUL DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED. HOWEVER THE PATIENT WAS EXPERIENCING SYNCOPAL EPISODES, AND AS A RESULT THERE WERE STILL POSSIBLE LEAD CONCERNS. SUBSEQUENTLY, THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock; Syncope/Fainting

  MAUDE report 16474002 ↗
• InjuryDec 14, 2022Signal Artifact/Noise; High impedance; Over-Sensing; High Capture Threshold; Signal Artifact/Noise; High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN THE PACING IMPEDANCE MEASUREMENT, REACHING HIGH OUT OF RANGE VALUES. THERE IS ALSO A SLIGHT INCREASE IN THE PACING THRESHOLD OBSERVED. FURTHER REVIEW BY TECHNICAL SERVICES (TS) INDICATED THAT PERFORMING TROUBLESHOOTING STEPS IS RECOMMENDED AND TO USE HIGH OUTPUT PACING FOR 5 TO 10 MINUTES AND RE-EVALUATE THE LEAD IMPEDANCE. UPON TROUBLESHOOTING AND HIGH OUTPUT PACING, THE PACING IMPEDANCE WAS OBSERVED TO DECREASE TO VALUES WITHIN NORMAL RANGE, INDICATING THAT IONIZATION COULD BE THE CAUSE OF THE GRADUAL INCREASE IN THE PACING IMPEDANCE. IT WAS ALSO NOTED THAT THE DEVICE OVERSENSED THE T-WAVE DURING HIGH OUTPUT PACING. THE PATIENT WILL CONTINUE TO BE MONITORED. ADDITIONAL INFORMATION PROVIDED INDICATES THE T-WAVE OVERSENSING WAS NOT ABLE TO BE REPRODUCED, SO DEVICE RE-PROGRAMMING WAS NOT PERFORMED BY THE CLINIC. IN ADDITION, THE PATIENT X-RAYS HAVE BEEN REVIEWED BY THE PHYSICIAN AND NO SIGNS OF LEAD IMPAIRMENT WERE OBSERVED. THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983246 ↗

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