PERCIVA™ ICD DR D401Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00802526587894), received between May 1, 2019 and Jul 28, 2026 — classified as 23 injuries, 26 malfunctions.

The most frequently reported specific device problem is “High impedance” (18 reports).

14 other recalls cover devices cleared under the same FDA submission (P960040); 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026High impedance; Off-Label Use

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060793 ↗
• MalfunctionMay 15, 2026Failure to Convert Rhythm; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED TO THE EMERGENCY ROOM (ER) AFTER BEING SHOCKED. THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) AND REQUESTED A CONSULT REVIEW OF THE PRESENTING ELECTROGRAM (EGM). UPON REVIEW, THE PRESENTING EGM SHOWED PATIENT WAS IN A VENTRICULAR ARRHYTHMIA. THE DEVICE DELIVERED A BURST OF ANTI-TACHYCARDIA PACING (ATP) AND SHOCK IN ATTEMPT TO CONVERT RHYTHM. THE THERAPY WAS UNABLE TO CONVERT THE RHYTHM. TS ALSO NOTED THERE TO BE UNDERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL. TS PROVIDED PROGRAMMING OPTIMIZATION AND RECOMMENDED FOR FURTHER EVALUATION BE PERFORMED BY CARDIOLOGY. AT THIS TIME, NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25180123 ↗
• MalfunctionApr 15, 2026Over-Sensing

  IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXHIBITING A RISING PACE IMPEDANCE MEASUREMENT. THE IMPEDANCES WERE STILL WITHIN NORMAL RANGE AND THE THRESHOLDS AND SENSING WERE BOTH CONFIRMED TO BE NORMAL. THERE WAS FAR FIELD OVERSENSING NOTED ON STRIP WHEN REVIEWED AND TECHNICAL SERVICES (TS) RECOMMENDED PROGRAMMING CHANGES. THE CHANGES WERE MADE AND ABLE TO PROGRAM AROUND THE OVERSENSING. TS ALSO RECOMMENDED FOLLOWING UP WITH POTENTIAL ISOMETRICS TO INDICATE A POTENTIAL LEAD FAILURE. THIS ICD AND RA LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887498 ↗
• InjuryMar 24, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACE DUE TO A NONSPECIFIC PRODUCT PERFORMANCE ANOMALY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681337 ↗
• MalfunctionMar 4, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MIGHT NOT BE WORKING CORRECTLY POST ECHOCARDIOGRAM AND ECHO. BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) REFERRED THE PATIENT TO THE CLINIC. AS OF THIS TIME, THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507315 ↗
• InjuryMar 2, 2026High impedance; Device Sensing Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS EXPERIENCING JUMPY IMPEDANCE MEASUREMENTS HIGH OUT OF RANGE. THE DEVICE RECORDED AN ATRIAL AUTOMATIC THRESHOLD (RAAT) TEST GREATER THAN PROGRAMMED AMPLITUDE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482488 ↗
• InjuryFeb 6, 2026Signal Artifact/Noise; Premature Discharge of Battery; Over-Sensing; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR PROJECTED REMAINING CAPACITY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. ADDITIONALLY, THIS PATIENT EXPERIENCED AN EPISODE IN WHICH 1 EARLY VENTRICULAR SENSE BLANKED OUT THE RIGHT ATRIAL (RA) BEAT. THE VENTRICLE BECAME GREATER THAN ATRIUM AND ANTI-TACHYCARDIA PACING (ATP) WAS INAPPROPRIATELY DELIVERED. TECHNICAL SERVICES (TS) PROVIDED PROGRAMMING OPTIMIZATION AND WHILE REVIEWING OBSERVED SOME PREVIOUS FALSE ATRIAL TACHY RESPONSE (ATR) EPISODES WITH NOISE ON BOTH THE RA AND SHOCK CHANNELS, WITH OVERSENSING ONLY ON THE RA. THIS ICD REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD THAT THE PHYSICIAN REQUESTED TO INCREASE THE LOWEST TACHY THERAPY ZONE TO PREVENT FURTHER INAPPROPRIATE ATP. THE PHYSICIAN AND PATIENT DISCUSSED DEVICE REPLACEMENT OPTIONS WITH NO DATE SET. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280162 ↗
• InjuryNov 19, 2025Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A VENTRICULAR TACHYCARDIA (VT) EPISODE WITH A RATE OF 180 BEATS PER MINUTE ON EXTERNAL TELEMETRY, HOWEVER, THE DEVICE DID NOT STORE THE EPISODE OR PROVIDE TREATMENT. THE PATIENT HAD TO BE EXTERNALLY SHOCKED. TECHNICAL SERVICES (TS) WAS CONTACTED AND DESCRIBED THE RATE NOT BEING FAST ENOUGH TO STORE IN THE VENTRICULAR FIBRILLATION (VF) ZONE AND CONCLUDED NORMAL DEVICE FUNCTION. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS ICD HAD BEEN EXPLANTED AND REPLACED DUE TO AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, AND THIS ICD HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598576 ↗
• InjuryOct 15, 2025Signal Artifact/Noise; Failure to Capture; Failure to Charge; High impedance; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Signal Artifact/Noise; Failure to Capture; Failure to Charge; High impedance; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED FAILURE TO CHARGE A CODE 1006, INDICATIVE OF A HIGH VOLTAGE DETECTED ON A LEAD DURING A DEVICE CHARGE. THE RIGHT VENTRICULAR (RV) CHANNEL EXHIBITED NOISE AND INTERMITTENT SHOCK IMPEDANCE MEASUREMENTS, WITH THE RECENT MEASUREMENTS BEING HIGH AND OUT OF RANGE. IT WAS ALSO NOTED THAT THE RV LEAD EXHIBITED LOSS OF CAPTURE AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES (TS) RECOMMENDED DEVICE REPLACEMENT. SUBSEQUENTLY, THIS ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED, AND THIS ICD HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300748 ↗
• MalfunctionSep 17, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS FOR ITS NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA, WITH NO OTHER ISSUES NOTED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073394 ↗
• InjurySep 2, 2025Signal Artifact/Noise; Telemetry Discrepancy; Interrogation Problem; Signal Artifact/Noise; Telemetry Discrepancy; Interrogation Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD EXHIBITED A POCKET INFECTION AND WAS SUCCESSFULLY REPLACED WITH A NON-BOSTON SCIENTIFIC DEVICE. ADDITIONALLY, DIFFICULTIES TO INTERROGATE AND NOISY SIGNALS WERE NOTED NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED OUTSIDE THE REVISION PROCEDURE. THIS PRODUCT HAS NOT BEEN RETURNED.

  Patient problems: Unspecified Infection

  MAUDE report 22935439 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO SUSPECTED INFECTION AND ALLERGIC REACTION. REPORTEDLY, THE PATIENT WAS FOR AN ATRIAL LEAD REVISION AND WHEN THE POCKET WAS OPENED, SOME SORT OF PUSS WAS NOTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS ICD WAS EXPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction; Purulent Discharge; Unspecified Infection

  MAUDE report 22698248 ↗
• MalfunctionJun 17, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THINK THAT IT WAS NOT WORKING. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22248494 ↗
• InjuryMay 15, 2025Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED EPISODES OF ATRIAL UNDERSENSING DURING RIGHT VENTRICULAR AUTOMATIC THRESHOLD (RVAT) TESTING, COINCIDING WITH RETROGRADE P-WAVES VISIBLE ON SURFACE ECG BUT NOT DETECTED BY THE DEVICE, POSSIBLY DUE TO PROGRAMMED SENSITIVITY THRESHOLDS. TECHNICAL SERVICES (TS) SUGGESTED REPROGRAMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028075 ↗
• MalfunctionApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  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 DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860087 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 20274941 ↗
• MalfunctionSep 11, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) AND REQUESTED FURTHER REVIEW OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STORED INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES DUE TO OBSERVED NOISY SIGNALS ON THE RIGHT ATRIAL (RA) AND SHOCK CHANNELS. UPON REVIEW OF THE EPISODES, TS CONFIRMED THE NOISY SIGNALS ON BOTH THE RA AND SHOCK CHANNELS. TS NOTED THAT THE NOISY SIGNALS WERE OVERSENSED AND APPEARED TO BE ELECTROMAGNETIC INTERFERENCE (EMI) IN NATURE. FURTHER REVIEW OF THE ATR EPISODES SHOWED THE INHIBITION OF ATRIAL PACING, NO ASYSTOLE OR INAPPROPRIATE THERAPY WAS OBSERVED. TS DISCUSSED POSSIBLE CAUSES OF THE EMI WITH THE HCP. AT THIS TIME, THE ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20196718 ↗
• MalfunctionAug 21, 2024High impedance; Battery Problem; Noise, Audible; High impedance; Battery Problem; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED WITH ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD, EXHIBITED A HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT GREATER THAN 200 OHMS. SHOCK IMPEDANCE MEASUREMENTS FLUCTUATED BETWEEN 80 AND >200 OHMS WITH CHANGES IN POSTURE AND POSITIONING. RV LEAD FRACTURE WAS SUSPECTED, AND LEAD REVISION WAS SCHEDULED. PRIOR TO THE PROCEDURE, THE PHYSICIAN DISCUSSED THE KEEPING THE CURRENT ICD VS. REPLACING THE ICD DURING THE SAME PROCEDURE. THE ICD WAS HAD BEEN IMPLANTED FOR 5 MONTHS AT THE TIME OF THE LEAD REVISION, BUT A BATTERY LONGEVITY ESTIMATE SHOWED APPROXIMATELY 4 YEARS REMAINING. TECHNICAL SERVICES (TS) EXPLAINED THAT LONG TELEMETRY SESSIONS OVER THE PAST WEEK TO EVALUATE THE RV LEAD APPEAR TO HAVE IMPACTED BATTERY LONGEVITY ESTIMATES. DURING THE LEAD REVISION, ADDITIONAL LEAD AND DEVICE EVALUATION IN THE POCKET FURTHER SUPPORTED THAT THE VARIABLE AND HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS WERE LIKELY ATTRIBUTED TO COMPROMISED RV LEAD INTEGRITY. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY A YEAR LATER REPORTED THAT THIS IMPLANTA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020838 ↗
• InjuryAug 16, 2024Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION AND DISPLAYING FAULT CODE 1003. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19998037 ↗
• InjuryJun 18, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND 2 INAPPROPRIATE SHOCKS DUE TO ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). DEVICE REMAINS IN SERVICE. TROUBLESHOOTING OPTIONS WERE DISCUSSED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19556825 ↗
• InjuryMay 27, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. LEADING TO INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). THE THERAPY WAS TURNED OFF. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED, AND THE ICD WAS EXPLANTED, WHILE THE RV LEAD WAS SURGICALLY ABANDONED. BOTH PRODUCTS WERE SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402252 ↗
• InjuryMay 15, 2024Connection Problem; Impedance Problem; Connection Problem; Impedance Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS AN ATTEMPTED IMPLANT AS THE ALREADY IN SERVICE LEAD COULD NOT BE INSERTED IN THE CRT-D PORT. DURING THIS PROCESS, A HIGH IMPEDANCE WAS MEASURED AT THE DISTAL COIL. THE RIGHT VENTRICULAR (RV) LEAD HAD TO BE SURGICALLY ABANDONED, A NEW RV LEAD AND CRT-D WERE IMPLANTED. DUE TO THIS SITUATION, THE PATIENT WAS SEDATED FOR FAR LONGER THAN USUAL. THE ATTEMPTED CRT-D HAS BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19327241 ↗
• InjuryNov 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN SAFETY MODE. THE FIELD REPRESENTATIVE WILL DISCUSS WITH THE PHYSICIAN ABOUT THE REPLACEMENT, AND IT WILL BE SENT FOR ANALYSIS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049936 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17995590 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17877939 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P960040. One submission often covers many models, so check the product and lot details in each record.

• Z-1670-2022 · 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-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-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, Sterile.
• Z-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, Sterile.
• Z-1555-2010 · Mar 15, 2010 · Terminated
  Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter Defibrillator (ICDs) are designed to detect and termina
• Z-0610-2010 · Dec 1, 2009 · Terminated
  Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethyle
• Z-1621-2009 · Mar 4, 2009 · Terminated
  GUIDANT VITALITY DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model T175 VR; 2EL ICD Model T167 DR; 2 EL ICD Model T177 VR; DS Model T125 DR. Implantable Cardi
• Z-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• Z-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• Z-0050-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant VITALITY DR HE (Model T180), Implantable Cardioverter Defibrillators (ICD). Guidant Corpor
• Z-0051-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, T177). Implantable Cardioverter Defibrillator, ICD. Guidant Corporation, 4100 Hamline A
• Z-1297-06 · Jun 24, 2006 · Terminated
  Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide.
• Z-1292-06 · May 15, 2006 · Terminated
  Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ven
• Z-0828-06 · Apr 7, 2006 · Terminated
  Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 551