Durata™ 7171-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05414734502443), received between Jun 19, 2018 and Apr 6, 2022 — classified as 1 death, 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “High impedance” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2022Break; Over-Sensing; Break; Over-Sensing

  IT WAS REPORTED THAT NOISE LEADING TO OVERSENSING WAS OBSERVED ON THE LOW VOLTAGE RIGHT VENTRICULAR (RV) LEAD, THE HIGH VOLTAGE RV LEAD, THE LEFT VENTRICULAR (LV) LEAD, AND RIGHT ATRIAL (RA) LEAD. ABNORMAL PACING IMPEDANCE WAS ALSO OBSERVED ON THE LV LEAD. THE NOISE LED TO INHIBITION OF PACING IN A PACING DEPENDENT PATIENT. LEAD DAMAGE WAS SUSPECTED BUT NO DIAGNOSTIC IMAGING WAS PERFORMED TO CONFIRM LEAD DAMAGE. THE NOISE COULD BE REPRODUCED WITH PROVOCATIVE TESTING. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES. RELATED MANUFACTURER RELATED REFERENCE NUMBER: 2017865-2022-07289, 2017865-2022-07287, 2017865-2022-07286.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14030352 ↗
• InjuryMar 1, 2022Fracture; Over-Sensing; Capturing Problem; Fracture; Over-Sensing; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. DEVICE INTERROGATION REVEALED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING NOISE THAT CAUSED INHIBITION OF PACING. THE LEAD ALSO HAD HIGH CAPTURE THRESHOLDS. A LEAD FRACTURE WAS SUSPECTED. NO INTERVENTION WAS PLANNED OR PERFORMED. THE PATIENT WAS STABLE THROUGHOUT THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637493 ↗
• InjurySep 22, 2020Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  DURING FOLLOW-UP, NOISE RESULTING IN OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE EVENT WAS RESOLVED BY CAPPING AND REPLACING THE RV LEAD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10566125 ↗
• MalfunctionOct 9, 2019Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH SEVERAL NON-SUSTAINED V OVERSENSING EPISODES DURING AN IN-CLINIC DEVICE CHECK. IT WAS NOTED THAT THE OVERSENSING APPEARED TO LEAD NOISE. THE POSSIBILITY OF THE LEAD RUBBING UP TO AN OLD ABANDONED LEAD CAUSING THE NOISE WAS BROUGHT UP. NO PROGRAMMING CHANGES WERE DONE TO ADDRESS THE ISSUE. THE PATIENT WOULD CONTINUE TO BE MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9173621 ↗
• DeathJun 7, 2019Signal Artifact/Noise; Break; Over-Sensing; Signal Artifact/Noise; Break; Over-Sensing

  DURING A FOLLOW-UP IN-CLINIC, NOISE RESULTING IN OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. SURGICAL INTERVENTION IS ANTICIPATED. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: Death; No Known Impact Or Consequence To Patient

  MAUDE report 8680363 ↗
• InjuryApr 25, 2019High impedance; High impedance

  IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING VIBRATORY PATIENT NOTIFICATION ALERT FOR HIGH, OUT OF RANGE RIGHT VENTRICULAR PACING LEAD IMPEDANCE. IN CLINIC DEVICE CHECK SHOWED NORMAL IMPEDANCE MEASUREMENTS BUT THE SESSION RECORD SHOWED NUMEROUS SPIKES. LEAD WAS CAPPED AND REPLACED ON (B)(6) 2019. DURING THE PROCEDURE, THE PATIENT WENT BRADYCARDIC AND HYPOTENSIVE BRIEFLY. PATIENT WAS STABILIZED WITH MEDICATION AND INCREASING THE PACING RATE ON THE DEVICE. PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 8553102 ↗
• MalfunctionApr 4, 2019High impedance; High impedance

  IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED IN CLINIC FOR A ROUTINE FOLLOW UP, INCREASE IN CAPTURE THRESHOLD AND PACING LEAD IMPEDANCE WERE OBSERVED. THE LEAD IMPEDANCE INCREASE WAS SIGNIFICANT. LEAD REVISION WILL BE SCHEDULED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8485020 ↗
• MalfunctionFeb 12, 2019High impedance; High impedance

  DURING FOLLOW-UP, HIGH DEFIBRILLATION IMPEDANCE WAS NOTED ON THE RIGHT VENTRICULAR LEAD. NO INTERVENTION WAS PERFORMED, THE LEAD REMAINS IMPLANTED AND WILL CONTINUE TO BE MONITORED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8331287 ↗
• InjuryDec 13, 2018High impedance; High Capture Threshold; High impedance; High Capture Threshold

  DURING A FOLLOW UP, HIGH CAPTURE THRESHOLD AND HIGH IMPEDANCE WERE NOTED ON THE RIGHT VENTRICULAR LEAD. THE LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT AND THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8160518 ↗
• MalfunctionDec 10, 2018Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR HEART FAILURE. UPON INTERROGATION OF THE DEVICE, REPRODUCIBLE NOISE WAS NOTED ON THE RIGHT VENTRICULAR LEAD. THE DEVICE HAD A HISTORY OF NOISE IN 2017 AND WAS REPROGRAMMED. THE PATIENT WAS STABLE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Heart Failure

  MAUDE report 8149371 ↗
• InjuryOct 15, 2018Break; High impedance; Break; High impedance

  IT WAS REPORTED THAT HIGH, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE ISSUE WAS OBSERVED ON THE LEAD. PATIENT WAS BEING MONITORED FOR THIS HIGH IMPEDANCE ISSUE SINCE THE PATIENT¿S DEVICE CHANGE OUT PROCEDURE IN (B)(6) 2018. PHYSICIAN OPTED TO IMPLANT A NEW LEAD DESPITE ON THAT DAY THE LEAD SHOWING NORMAL RANGE IMPEDANCE VALUES. UPON LEAD REVISION PROCEDURE, PHYSICIAN OBSERVED A SMALL INSULATION BREACH WHICH APPEARED TO HAVE BEEN CUT. LEAD WAS CAPPED ON (B)(6) 2018 AND A NEW LEAD WAS IMPLANTED. PATIENT WAS STABLE PRIOR, DURING AND POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7965422 ↗
• InjuryJun 19, 2018High impedance; High impedance

  DURING FOLLOW-UP, INCREASED IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN ALLEGES THE LEAD WAS DAMAGED AT THE PRIOR DEVICE REPLACEMENT DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR. DIAGNOSTIC IMAGING WAS INCONCLUSIVE. THE ISSUE WAS RESOLVED BY CAPPING AND REPLACING THE RV LEAD. THE PATIENT WAS IN STABLE CONDITION AND EXPERIENCED NO ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7613193 ↗

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-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
• 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