Durata™ 7171Q-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 05414734503280), received between Aug 27, 2018 and Jun 8, 2026 — classified as 44 injuries, 14 malfunctions.

The most frequently reported specific device problem is “High impedance” (28 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026High impedance

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH HIGH DEFIBRILLATION IMPEDANCE NOTED ON THE PATIENT'S RIGHT VENTRICULAR LEAD. TECHNICAL SERVICES WAS CONTACTED AND CONFIRMED THE PATIENT HAD CHRONICALLY HIGH IMPEDANCE. THE LEAD WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25430609 ↗
• InjuryFeb 20, 2026Signal Artifact/Noise; Over-Sensing

  NEW INFORMATION RECEIVED INDICATES THAT THE PATIENT PRESENTED IN THE CLINIC. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING. THE RV LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24404911 ↗
• InjuryMar 21, 2025Break; Over-Sensing; Break; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC. IT WAS FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVER-SENSING NOISE DUE TO A SUSPECTED INSULATION ANOMALY. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668429 ↗
• MalfunctionMay 21, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED LOW DEFIB IMPEDANCE. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19366328 ↗
• InjuryNov 10, 2023High impedance; Over-Sensing; High impedance; Over-Sensing

  NEW INFORMATION RECEIVED NOTES THAT THE LEAD WAS CAPPED AND REPLACED DUE TO OVER-SENSED NOISE AND HIGH PACING IMPEDANCE ON 10 SEP 2024. THE PATIENT WAS STABLE PRIOR TO, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18116722 ↗
• InjuryNov 9, 2023High impedance; Capturing Problem; High impedance; Capturing Problem

  NEW INFORMATION RECEIVED NOTES THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED IN A PROCEDURE ON (B)(6) 2023. POST-PROCEDURE THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103931 ↗
• InjuryJun 23, 2023Failure to Convert Rhythm; Low impedance; Charging Problem; Failure to Convert Rhythm; Low impedance; Charging Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC DUE TO AN ARRHYTHMIA. DEVICE INTERROGATION REVEALED HIGH DEFIBRILLATION IMPEDANCE, HIGH CAPTURE THRESHOLDS, OCD ALERT ON THE RIGHT VENTRICULAR (RV) LEAD. NO CHANGES OR INTERVENTIONS WERE PERFORMED. THE PATIENT WAS IN UNSTABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 17195519 ↗
• MalfunctionJun 2, 2023Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Device Sensing Problem; Device Dislodged or Dislocated; Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Device Sensing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DURING CLINICAL FOLLOW-UP. UPON INTERROGATION IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCE, FAILURE TO CAPTURE, NOISE, AND DIMINISHED SENSING. DISLODGEMENT WAS NOTED AND FRACTURE WAS SUSPECTED. NO INTERVENTIONS WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052239 ↗
• InjuryFeb 3, 2023Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED A PATIENT PRESENTED IN THE HOSPITAL FOR HEART FAILURE SYMPTOMS AND FATIGUE. THE DEVICE WAS INTERROGATED AND SHOWED NO CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD WITH HIGH PACING IMPEDANCE. THE RV LEAD WAS CAPPED AND REPLACED IN A PROCEDURE ON (B)(6) 2023. POST-PROCEDURE THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia; Fatigue

  MAUDE report 16294681 ↗
• InjuryNov 22, 2022High impedance; Over-Sensing; Device Sensing Problem; High impedance; Over-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT HIGH PACING IMPEDANCE AND NOISE WAS OBSERVED ON A REMOTE TRANSMISSION ON (B)(6) 2022. PROGRAMMING CHANGE WAS MADE WHEN NOISE WAS SENSED AND BINNED AS VENTRICULAR FIBRILLATION ON (B)(6) 2022. IN BEGINNING OF AUGUST 2022, A RISE IN PACING IMPEDANCE, DECREASED IN R-WAVES AND EPISODES NOISE REVISION WERE NOTED. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED, AND A NEW RV LEAD WAS IMPLANTED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15843755 ↗
• InjuryAug 25, 2022High impedance; Device Sensing Problem; High impedance; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCE AND R-WAVE AMPLITUDE VARIATION. NO INTERVENTION WAS PERFORMED AND THE PATIENT WOULD BE EVALUATED FOR LEAD REVISION. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298874 ↗
• InjuryMay 27, 2022High impedance; Over-Sensing; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A REMOTE FOLLOW UP VIA MERLIN.NET WITH BRADYCARDIC EVENTS AND A RIGHT VENTRICULAR (RV) LEAD THAT EXHIBITED NOISE OVER-SENSING AND HIGH PACING IMPEDANCE. PROGRAMMING CHANGES WERE MADE. THE PATIENT THEN PRESENTED IN CLINIC ON (B)(6) 2022. THE RV LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 14527581 ↗
• InjuryMay 7, 2022Break; Over-Sensing; Break; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON REVIEW, THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE LEADING TO OVER-SENSING. THE PATIENT PRESENTED TO A SCHEDULED EXPLANT PROCEDURE. DURING THE PROCEDURE, WHILE REMOVING THE LEAD, THE TIP ELECTRODE WAS DAMAGED. THE LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317335 ↗
• InjuryApr 27, 2022High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON REVIEW, THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCE AND CAPTURE THRESHOLD. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14228606 ↗
• MalfunctionMar 9, 2022Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FAILURE TO CAPTURE. NO PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13712514 ↗
• InjuryMar 3, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664610 ↗
• MalfunctionOct 13, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SCHEDULED PROCEDURE. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED INSULATION DAMAGE. THE INNER INSULATION APPEARED TO BE INTACT. THE PHYSICIAN OPTED TO REPAIR THE LEAD WITH EXTRA INSULATION AND KEEP IT IN PLACE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627665 ↗
• InjuryMay 3, 2021Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW-UP ON (B)(6) 2021. DURING EXAMINATION OF LEAD, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS NOT CAPTURING. THE PHYSICIAN DOES NOT KNOW THE REASON FOR THIS LOSS OF CAPTURE. THE RV LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD WHICH HAD NORMAL CAPTURE THRESHOLD VALUES ON (B)(6) 2021. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11761263 ↗
• MalfunctionApr 27, 2021High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT ASYMPTOMATIC PATIENT PRESENTED FOR FOLLOW UP IN CLINIC ON APR 6, 2021. UPON INTERROGATION, IT WAS NOTED THAT RIGHT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLD AND HIGH PACING IMPEDANCE. IT WAS NOTED THAT THE VALUES INCREASED FROM (B)(6) 2020 TO (B)(6) 2021 AND STABILIZED AT THE CURRENT VALUES. NO INTERVENTION WAS PERFORMED AND THE PATIENT IS AWAITING FOR A LEAD REPLACEMENT PROCEDURE. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734817 ↗
• InjuryMar 22, 2021Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2021. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548062 ↗
• InjuryMar 9, 2021Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A FOLLOW UP. INTERROGATION SHOWED THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD CAPTURE THRESHOLD WAS HIGH. THE PATIENT WAS ASYMPTOMATIC. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449007 ↗
• InjuryJan 25, 2021Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. THE LEAD WAS CAPPED ON (B)(6) 2021. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11227866 ↗
• InjuryJan 19, 2021High impedance; High impedance

  IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED WITH THEIR RIGHT VENTRICULAR LEAD EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2021. PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197988 ↗
• InjuryJan 11, 2021Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT PRESENTED IN-CLINIC. UPON CHEST X-RAY, THE RIGHT VENTRICULAR LEAD WAS SHOWN TO BE DISLODGED. THE LEAD ALSO FAILED TO CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2020. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11152878 ↗
• InjuryNov 16, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SCHEDULED PROCEDURE. IT WAS DISCOVERED THAT THE RIGHT VENTRICULAR EXHIBITED HIGH CAPTURE THRESHOLDS. THE LEAD WAS CAPPED ON (B)(6) 2020. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10848966 ↗

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