EASYTRAK® 2 4517Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00802526417665), received between Oct 28, 2013 and Apr 29, 2026 — classified as 53 injuries, 22 malfunctions.

The most frequently reported specific device problem is “High impedance” (30 reports).

19 other recalls cover devices cleared under the same FDA submission (P010012); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE LEAD WAS PART OF THE S SYSTEM REVISION DUE TO INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE IMPLANTABLE LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25026004 ↗
• MalfunctionJul 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS FRACTURED. THE PHYSICIAN DID NOT WANT TO MAKE ANY CHANGES YET. TO DATE, THIS LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22431640 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21969558 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20290423 ↗
• InjuryAug 1, 2024High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. THIS PATIENT EXPERIENCED MUSCLE STIMULATION. AN XRAY WILL BE PERFORMED TO CONFIRMED LEAD INTEGRITY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED REPROGRAMMING OPTIONS. THE LEAD WAS CAPPED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 19888070 ↗
• InjuryJul 17, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE, THE PHYSICIAN DECIDED TO REPLACE THIS LEFT VENTRICULAR (LV) LEAD DUE TO KNOWN PATIENT EXPERIENCE OF DIAPHRAGMATIC STIMULATION. THE LV LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 19763668 ↗
• MalfunctionJul 10, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS, MEASURING GREATER THAN 3000 OHMS. TECHNICAL SERVICES (TS) REVIEWED AND STATED THAT THE DEVICE IS REACHING END OF LIFE (EOL) IN NORMAL TIMEFRAME. THIS LV LEAD CURRENTLY REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711548 ↗
• MalfunctionJul 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LEAD FRACTURE. PATIENT HAS A NARROW QUALITATIVE REFERENCE STANDARDS AND IS PROGRAMMED TO RIGHT VENTRICULAR ONLY. PHYSICIAN IS NOT INTERVENING ON LV LEAD AND MONITORING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT EXTENDING ATRIOVENTRICULAR (AV) DELAYS IS THE ONLY OPTION. HEALTH CARE PROFESSIONAL (HCP) STATES PATIENT AV DELAY WAS SET. THIS LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19675228 ↗
• MalfunctionJun 18, 2024High impedance; Connection Problem; High impedance; Connection Problem

  IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD COULD NOT BE INSERTED ALL OF THE WAY INTO THE HEADER OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DURING GENERATOR CHANGE OUT PROCEDURE. THIS PRODUCED SHOCK IMPEDANCE MEASUREMENTS THAT WERE GREATER THAN 200 OHMS WHICH WAS HIGH OUT OF RANGE. MULTIPLE ATTEMPTS AT TROUBLESHOOTING WERE PERFORMED INCLUDING CLEANING THE TERMINAL PIN AND REINSERTION. ULTIMATELY, THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE WITH THE OUT OF RANGE MEASUREMENTS AND RE-EVALUATE DURING FOLLOW-UP APPOINTMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE OF THE PROLONGED PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557702 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF SYSTEM REVISION DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 19337870 ↗
• InjuryMar 21, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED A HIGH PACING THRESHOLD. THIS LEAD WAS SURGICALLY ABANDONED, AND A NEW LEAD WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THIS DEVICE WAS SURGICALLY EXPLANTED DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 18956451 ↗
• InjuryJan 16, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR LEAD WAS SURGICALLY ABANDONED DUE TO EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. ANOTHER LEAD WAS IMPLANTED INSTEAD. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519955 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17203886 ↗
• MalfunctionFeb 3, 2023Failure to Capture; No Apparent Adverse Event; High Capture Threshold; Failure to Capture; No Apparent Adverse Event; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED A NON-SPECIFIC DEVICE PRODUCT PERFORMANCE ISSUE. AN ALERT TO CHECK THE LEAD WAS TRIGGERED ON LATITUDE. THE HEALTH CARE PROFESSIONAL (HCP) STATES IS A KNOWN ISSUE. NO FURTHER INFORMATION WAS PROVIDED. THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THE LEAD WAS TURNED OFF DUE TO HIGH PACING THRESHOLDS AND LOSS OF CAPTURE (LOC). THIS LEAD WAS RECENTLY TESTED DURING A GENERAL DEVICE CHANGE-OUT PROCEDURE AND FOUND TO BE FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292758 ↗
• InjuryFeb 3, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD PRESENTED HIGH PACING THRESHOLDS. THIS LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292532 ↗
• MalfunctionDec 20, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD SHOWED HIGH, OUT OF RANGE PACING IMPEDANCES FOR MOST PART OF THE YEAR. THE VALUE IS CONSISTENTLY HIGH. THE LV LEAD SENSING HAD BEEN PROGRAMMED OFF. THERE WERE NO RELATED CASES TO SAY WHY THESE CHANGES WERE MADE. BOSTON SCIENTIFIC TECHNICAL SERVICES DISCUSSED WITH THE CALLER DESIGN CHARACTERISTICS AND MENTIONED THE POSSIBILITY AN ISSUE THROUGH CONDUCTORS DUE TO THE IMPEDANCE MEASUREMENT BEHAVIOR. NO CHANGES WERE RECOMMENDED AT THIS TIME AS IT WAS UNKNOWN WHY THE DEVICE HAD BEEN PROGRAMMED THE WAY IT WAS IN THE PAST. THE LV LEAD REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018737 ↗
• InjuryDec 8, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A LEFT VENTRICULAR (LV) LEAD WAS SURGICALLY ABANDONED 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 15941198 ↗
• InjuryDec 8, 2022No Apparent Adverse Event; High Capture Threshold; No Apparent Adverse Event; High Capture Threshold

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS CAPPED DUE TO A PRODUCT PERFORMANCE ISSUE. ANOTHER LEAD WAS PLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940963 ↗
• InjurySep 29, 2022High impedance; High impedance

  THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND LEFT VENTRICULAR (LV) LEAD TRIGGERED A LEAD SAFETY SWITCH (LSS) TO UNIPOLAR DUE TO A HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENT OF 2,012 OHMS. THE VECTOR WAS REPROGRAMMED SUCCESSFULLY AND THE LSS FOR THE LV LEAD WAS PROGRAMMED OFF. THIS CRT-P AND LV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505356 ↗
• MalfunctionAug 17, 2022Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 3000 OHMS. ALL OTHER LV LEAD MEASUREMENTS WERE STABLE. NO CHANGES HAVE BEEN MADE AND THE LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15240056 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 14107231 ↗
• InjuryApr 9, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS. THIS MEASUREMENT COINCIDED WITH A TIME IN WHICH THE PATIENT HAD REPORTED EXPERIENCING A FALL. NO CHANGES HAVE BEEN MADE AND THE LV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 14068821 ↗
• InjuryApr 9, 2022Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Low impedance; Connection Problem; Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Low impedance; Connection Problem

  IT WAS REPORTED THAT THIS PATIENT'S LEFT VENTRICULAR (LV) LEAD SHOWED CONNECTION ISSUES WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) USING A LV-1 TO IS-1 ADAPTER. THE PHYSICIAN STRUGGLED TO GET THE TIP SETSCREW SECURE DURING THE PROCEDURE. THE PHYSICIAN SCREW AND UNSCREW THE LEAD SEVERAL TIMES AND LATER FELT IT WAS SECURED. ADEQUATE LEAD MEASUREMENTS WERE EVIDENCED, AND THE PROCEDURE WAS COMPLETED. THE NEXT MORNING DURING THE PATIENT DISCHARGE, THE ELECTROGRAM SHOWED FLAT SIGNALS ON THE LV CHANNEL. TECHNICAL SERVICES RECOMMENDED TO REPROGRAM THE LV LEAD POLARITY; HOWEVER, HIGH IRREGULAR IMPEDANCE WAS SEEN REACHING MEASUREMENTS OVER 3000 OHMS. TECHNICAL SERVICES INDICATED THIS PATIENT'S CRT-D IS PROBABLY NOT MAKING APPROPRIATE CONTACT WITH THE TERMINAL PIN OF THE LV LEAD INTERMITTENTLY. X-RAYS WERE RECOMMENDED TO EVALUATE THIS POSSIBILITY. FURTHER INFORMATION WAS RECEIVED INDICATING THAT A WEEK LATER FOLLOW UP, DID NOT SHOWED HIGH PACING IMPEDANCE MEASUREMENTS AND NO X-RAYS WERE PERFORMED. REPORTEDLY, AN INFECTION WAS NOTICED LESS THAN 2 WEEKS LATER OF THE IMPLANT PROCEDURE AND LOW PACING IMPEDANCE MEASUREMENTS OUT-OF-RANGE WERE ALSO NOTICED. THE PATIENT WAS ADMI

  Patient problems: Unspecified Infection

  MAUDE report 14068773 ↗
• MalfunctionApr 7, 2022Failure to Capture; Fracture; High impedance; High Capture Threshold; Failure to Capture; Fracture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT ATTENDED CLINIC FOR A ROUTINE FOLLOW-UP APPOINTMENT, AND INDICATED HEARING BEEPING TONES COMING FROM THE RELATED PULSE GENERATOR (PG). DURING DEVICE INTERROGATION, IT WAS FOUND THAT THE PG HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AS EXPECTED. UNEXPECTEDLY, IT APPEARED THAT THIS THIS LEFT VENTRICULAR (LV) LEAD HAD A SUSPECTED FRACTURE BECAUSE IT WAS NOT CAPTURING ON PRESENTATION. THE PATIENT ALSO INDICATED THAT HE WAS EXPERIENCING SHORTNESS OF BREATH, AND THAT HIS LEGS HAD BECOME MORE SWOLLEN. THE LEAD TREND GRAPH SHOWED A CHANGE IN IMPEDANCE MEASUREMENTS, WHICH WERE HIGH AND OUT OF RANGE. THE LV LEAD CONFIGURATIONS WERE TESTED, CONFIRMING THAT THE IMPEDANCES WERE GREATER THAN 2500 OHMS, AND HIGH CAPTURE THRESHOLDS WERE ALSO OBSERVED. SINCE THE PATIENT HAD GOOD UNDERLYING RHYTHM, THE PHYSICIAN ELECTED TO REPROGRAM DEVICE SETTINGS. THE PATIENT HAS BEEN SCHEDULED FOR ROUTINE REPLACEMENT OF THE RELATED PG; THEREFORE, IT IS INTENDED THAT THIS LEAD WILL BE REPLACED AT THE SAME TIME. THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Swelling/ Edema

  MAUDE report 14048940 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS PART OF A SYSTEM REVISION DUE TO POCKET EROSION AND INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LV LEAD WAS EXPLANTED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 14032290 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010012. One submission often covers many models, so check the product and lot details in each record.

• Z-1671-2022 · Jul 7, 2022 · Open, Classified
  The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all
• Z-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, Sterile.
• Z-0079-2018 · Oct 4, 2017 · Terminated
  VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharma
• Z-1556-2010 · Mar 15, 2010 · Terminated
  Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillat
• Z-0609-2010 · Dec 1, 2009 · Terminated
  Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107,
• Z-1049-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
• Z-1055-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are design
• Z-1053-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventric
• Z-1047-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North,
• Z-1054-2007 · Mar 23, 2007 · Terminated
  VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 U
• Z-1052-2007 · Mar 23, 2007 · Terminated
  VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. P
• Z-0047-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872.
• Z-1288-06 · May 15, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Ave
• Z-0826-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Ha

…and 4 more.