Durata™ 7171Q-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 05414734503297), received between Aug 9, 2018 and Sep 2, 2026 — classified as 4 deaths, 19 injuries, 17 malfunctions.

The most frequently reported specific device problem is “High impedance” (17 reports).

3 other recalls cover devices cleared under the same FDA submission (P950022); 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50555083 ↗
• MalfunctionJun 10, 2026Break; Over-Sensing

  DURING A REMOTE FOLLOW UP, POST SENSED T-WAVE OVERSENSING WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. RV LEAD DAMAGE WAS SUSPECTED BUT THIS WAS NOT CONFIRMED. NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS STABLE AND WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456468 ↗
• InjuryFeb 17, 2026High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE AND HIGH CAPTURE THRESHOLDS, WHILE THE RIGHT ATRIAL (RA) LEAD WAS OVER-SENSING NOISE WHICH WAS SUSPECTED TO BE CAUSED BY AN INSULATION BREAK. THE PATIENT WAS ASYMPTOMATIC. THE RV AND RA LEADS WERE EXPLANTED AND REPLACED SUCCESSFULLY. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366547 ↗
• InjuryDec 29, 2025High impedance; High impedance

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCE. THE LEAD WAS CAPPED ON (B)(6) 2025 AND SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918244 ↗
• InjuryDec 10, 2025Over-Sensing; Insufficient Device Problem Information; Over-Sensing; Insufficient Device Problem Information

  NEW INFORMATION WAS RECEIVED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING OF NOISE. THE PATIENT WAS STABLE FOLLOWING EXPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770770 ↗
• MalfunctionOct 29, 2025High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT PROGRAMMING CHANGES WERE MADE TO RESOLVE THE ISSUE. THE PATIENT REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420904 ↗
• MalfunctionAug 26, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH DEFIBRILLATION IMPEDANCE. NO INTERVENTION WAS PERFORMED, AND THE PATIENT'S STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895487 ↗
• MalfunctionJun 9, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET WITH RECORDED EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVER-SENSING. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING. PROGRAMMING CHANGES WERE MADE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22170405 ↗
• InjuryOct 25, 2024Failure to Deliver Shock/Stimulation; Low impedance; Charging Problem; Failure to Deliver Shock/Stimulation; Low impedance; Charging Problem

  IT WAS REPORTED, THAT THE PATIENT RECEIVED A SHOCK FOR A TRUE VT EVENT. HOWEVER, THERE WAS AN ALERT INDICATING "POSSIBLE HIGH VOLTAGE LEAD ISSUE. ALTERNATIVE SHOCK CONFIGURATIONS HAVE BEEN ATTEMPTED". IT WAS NOTED, THAT THE THIRD ATTEMPTED SHOCK CONFIGURATION WAS SUCCESSFUL AT CONVERTING THE ARRHYTHMIA. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2024. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Arrhythmia

  MAUDE report 20538980 ↗
• DeathNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE, CARDIOMYOPATHY, CORONARY ARTERY DISEASE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18165642 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-35790, RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-35791, RELATED MANUFACTURER REFERENCE NUMBERS: 2017865-2023-35793. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP DUE TO POCKET WOUND DEHISCENCE. IT WAS DETERMINED THAT THE PATIENT HAD DEVELOPED INFECTION AND SUFFERED FROM SUSPECTED ENDOCARDITIS. THE WHOLE SYSTEM INCLUDING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT VENTRICULAR LEAD, RIGHT ATRIAL LEAD AND LEFT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED BY A LEADLESS PACEMAKER. THE PATIENT WAS DISCHARGED.

  Patient problems: Unspecified Infection

  MAUDE report 17321417 ↗
• MalfunctionMar 28, 2023Failure to Capture; Device Sensing Problem; Failure to Capture; Device Sensing Problem

  DURING THE PREPARATION FOR A ROUTINE DEVICE REPLACEMENT PROCEDURE, A LOSS OF CAPTURE AND R WAVE AMPLITUDE VARIATION WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. DURING THE DEVICE REPLACEMENT PROCEDURE, THE RV LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629487 ↗
• MalfunctionNov 11, 2022High impedance; High impedance

  IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC. UPON INTERROGATION, THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO HAVE HIGH IMPEDANCE. SURGICAL INTERVENTION WAS PLANNED, BUT NO ADDITIONAL INTERVENTION WAS REPORTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15784272 ↗
• InjuryNov 4, 2022Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Material Twisted/Bent; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Material Twisted/Bent

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-44203, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-44205. IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCK FROM THE RIGHT VENTRICULAR (RV) LEAD DUE TO NOISE OVERSENSING. DEVICE INTERROGATION REVEALED HIGH PACING IMPEDANCE ON THE RV LEAD AND PREMATURE BATTERY DEPLETION ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV LEAD AND ICD. DURING THE PROCEDURE THE RV LEAD WAS NOTED TO BE BENT AND FRACTURED. THE LEFT VENTRICULAR (LV) LEAD WAS DISLODGED DURING THE PROCEDURE AND WAS EXPLANTED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729702 ↗
• InjuryApr 11, 2022Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Device Sensing Problem; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR A FOLLOW UP IN CLINIC WITH A RIGHT VENTRICULAR LEAD THAT EXHIBITED LEAD NOISE, R-WAVE AMPLITUDE VARIATION, AND HIGH PACING IMPEDANCE DUE TO SUSPECTED CONDUCTOR FRACTURE. LEAD REVISION WAS DISCUSSED; NO INTERVENTIONS WERE REPORTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079310 ↗
• InjuryMar 16, 2022High impedance; High impedance

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED FOR A FOLLOW UP WITH A RIGHT VENTRICULAR LEAD THAT EXHIBITED HIGH PACING IMPEDANCE. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13777179 ↗
• InjuryNov 2, 2021Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT PRESENTED FOR A FOLLOW UP. THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING NOISE. THE PATIENT RECEIVED INAPPROPRIATE THERAPY AND HAD VERY VIOLENT EPISODES OF VOMITING. THE RV LEAD WAS SUSPECTED TO BE DISLODGED. THE DEVICE WAS REPROGRAMMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Discomfort

  MAUDE report 12740264 ↗
• InjurySep 20, 2021High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC. UPON INTERROGATION, IT WAS OBSERVED THE RIGHT VENTRICULAR LEAD HAD HIGH CAPTURE THRESHOLD AND HIGH PACING IMPEDANCE OF 1325 OHMS. THE LEAD WAS CAPPED ON (B)(6) 2021. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497172 ↗
• DeathJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-22992, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-22994, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-22995. IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THE CAUSE OF DEATH WAS REPORTED TO BE CARDIOGENIC SHOCK WITH ACUTE ON CHRONIC SYSTOLIC HEART FAILURE AND ISCHEMIC CARDIOMYOPATHY. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED.

  Patient problems: Heart Failure/Congestive Heart Failure; Ischemic Heart Disease

  MAUDE report 12025609 ↗
• MalfunctionMar 22, 2021Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSIONS REVEALED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED LOW PACING IMPEDANCE. NO DEVICE INTERVENTION WAS PERFORMED AND THE PATIENT WILL BE MONITORED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547805 ↗
• DeathJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-06504. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-06507. IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO CARDIORESPIRATORY ARREST FROM CHRONIC HEART FAILURE AND ISCHEMIC DYSFUNCTION. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11254853 ↗
• InjuryNov 5, 2020Low impedance; Charging Problem; Naturally Worn; Low impedance; Charging Problem; Naturally Worn

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2020-17259. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING THREE SUCCESSFUL SHOCKS FOR VENTRICULAR TACHYCARDIA. DEVICE INTERROGATION REVEALED ALERTS FOR A SHORTED OUTPUT STAGE AND OVER CURRENT DETECTION. DEFIBRILLATION IMPEDANCE MEASURED BELOW THE LOWER LIMIT. THE PATIENT WAS ADMITTED TO THE HOSPITAL. WHILE AWAITING DEVICE REPLACEMENT THE PATIENT EXPERIENCED A SLOW VENTRICULAR TACHYCARDIA EPISODE; HOWEVER, THE DEVICE WAS FOUND IN BACKUP OPERATION AND THE PATIENT REQUIRED EXTERNAL DEFIBRILLATION. THE DEVICE WAS ABLE TO BE PROGRAMMED TO AN APPROPRIATE PACING RATE. DURING THE REPLACEMENT PROCEDURE THE LEAD WAS FOUND TO HAVE WORN INSULATION WHERE IT WAS COILED UNDER THE CAN. ON (B)(6) 2020 THE DEVICE WAS EXPLANTED AND RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED. THERE WERE NO FURTHER PATIENT CONSEQUENCES.

  Patient problems: Arrhythmia

  MAUDE report 10796595 ↗
• MalfunctionOct 1, 2020High impedance; High impedance

  IT WAS REPORTED THAT PATIENT RECEIVED A VIBRATORY ALERT AND SENT A REMOTE MERLIN.NET TRANSMISSION. REVIEW OF TRANSMISSION REVEALED THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCES. THE PATIENT WAS BROUGHT INTO CLINIC FOR CHEST X-RAY. THERE WERE NO CONSEQUENCES TO THE PATIENT. THE PATIENT¿S EJECTION FRACTION INCREASED, SO NO INTERVENTION WAS PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10613168 ↗
• InjuryAug 21, 2020Signal Artifact/Noise; Low impedance; Signal Artifact/Noise; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED RECEIVED A VIBRATORY ALERT ON (B)(6) 2020. THE PATIENT PRESENTED IN CLINIC AND DEVICE INTERROGATION REVEALED THAT IMPEDANCE WAS LOW. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2020. PRIOR TO PROCEDURE, LEAD NOISE WAS ALSO OBSERVED. PATIENT WAS STABLE THROUGHOUT EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10437650 ↗
• MalfunctionJul 6, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN ATRIAL AND LEFT VENTRICULAR LEAD IMPLANT. DURING THE PROCEDURE, IT WAS NOTED THAT THE SUTURE SLEEVE OF THE IMPLANTED RIGHT VENTRICULAR LEAD HAD SPLIT. THE SUTURE SLEEVE WAS REMOVED AND REPLACED. THE PATIENT EXPERIENCED NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10235319 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P950022. One submission often covers many models, so check the product and lot details in each record.

• Z-0660-2016 · Nov 3, 2015 · Terminated
  Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Car
• Z-0457-2012 · Nov 28, 2011 · Terminated
  St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product Usage: These Silicone transvenous high voltage (HV) leads co
• Z-0458-2012 · Nov 28, 2011 · Terminated
  St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata(7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 Product Usage: These Silicone transvenous