Durata™ 7170Q-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 05414734503259), received between Jul 2, 2018 and Sep 9, 2026 — classified as 3 deaths, 97 injuries, 66 malfunctions.

The most frequently reported specific device problem is “High impedance” (59 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 166 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Fracture; High impedance

  It was reported that the patient's Right Ventricular (RV) lead exhibited high pacing impedance, indicating a suspected lead fracture. The physician elected to explant the RV lead and replace it with a new one. The patient's condition remained stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693990 ↗
• InjurySep 3, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50596638 ↗
• InjuryJul 3, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE DAY POST-IMPLANT DEVICE CHECK, THE RIGHT VENTRICULAR (RV) LEAD WAS NOT CAPTURING. X-RAY AND FLUOROSCOPY WERE PERFORMED AND SHOWED LEAD DISLODGEMENT. THE RV LEAD WAS EXPLANTED AND REPLACED WITH AN ACTIVE LEAD. THE PATIENT WAS IN STABLE CONDITION WITH NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25709179 ↗
• MalfunctionJun 19, 2026High impedance

  DURING A FOLLOW-UP IN-CLINIC, AN INCREASE IN DEFIBRILLATION IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. REPROGRAMMING WAS PERFORMED TO RESOLVE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561743 ↗
• InjuryApr 9, 2026Fracture; High impedance

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH A FRACTURE NOTED ON THE RIGHT VENTRICULAR LEAD. THIS RESULTED IN HIGH PACING IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. NO INFORMATION REGARDING ADVERSE PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24833276 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC WITH A POCKET INFECTION AND EXPERIENCED REDNESS, SWELLING AND DISCHARGE. THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD), RIGHT ATRIAL (RA) LEAD, HIGH VOLTAGE RIGHT VENTRICULAR (HV -RV) LEAD AND LOW VOLTAGE RIGHT VENTRICULAR (LV-RV) LEAD WERE EXPLANTED DUE TO THE INFECTION. DUAL CHAMBER LEADLESS PACEMAKER WAS IMPLANTED ON THE (B)(6) 2025. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Unspecified Infection

  MAUDE report 24032908 ↗
• MalfunctionDec 22, 2025High impedance; High impedance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865407 ↗
• InjuryOct 30, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT A LEAD REVISION WAS PERFORMED TO THE RIGHT VENTRICULAR LEAD DUE TO THE LEAD NOT CAPTURING. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429771 ↗
• MalfunctionAug 18, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE DEVICE CHANGE OUT PROCEDURE. PRIOR TO THE PROCEDURE, UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED EPISODES OF OVER-SENSED NOISE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835374 ↗
• InjuryJun 12, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A RIGHT-VENTRICULAR (RV) LEAD EXPLANT PROCEDURE DUE TO RV LEAD HIGH CAPTURE THRESHOLD. AS A RESOLUTION THE RV LEAD WAS EXPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196092 ↗
• MalfunctionApr 4, 2025Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 21777833 ↗
• InjuryMar 25, 2025High impedance; Defective Device; Insufficient Device Problem Information; High impedance; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WAS REFERRED FOR A RIGHT VENTRICULAR (RV) LEAD REVISION DUE TO HIGH PACING IMPEDANCE AND LEAD NO LONGER FUNCTIONING. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV LEAD. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692923 ↗
• DeathMar 13, 2025Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT HAD DECEASED DUE TO AN UNKNOWN CAUSE AND FAILURE TO DELIVER SHOCK WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE RIGHT VENTRICULAR (RV) LEAD. NO ADDITIONAL INFORMATION WAS REPORTED.

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

  MAUDE report 21597466 ↗
• InjuryFeb 26, 2025Capturing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED CAPTURE ISSUE ON THE RIGHT VENTRICULAR (RV) LEAD; THE RV LEAD WAS FOUND TO BE DISLODGED. ON (B)(6) 2025, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RV LEAD. THE PATIENT CONDITION WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469848 ↗
• MalfunctionJan 21, 2025Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 21203137 ↗
• MalfunctionSep 6, 2024Failure to Capture; Device Sensing Problem; Failure to Capture; Device Sensing Problem

  IT WAS REPORTED THAT PATIENT PRESENTED FOR SCHEDULED PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT LEAD EXHIBITED FAILURE TO CAPTURE AND POOR SENSING. THE LEAD WAS ULTIMATELY NOT USED AND REPLACED WITH NEW LEAD. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163476 ↗
• InjuryAug 15, 2024Failure to Capture; Fracture; High impedance; Failure to Sense; Failure to Capture; Fracture; High impedance; Failure to Sense

  IT WAS REPORTED THAT DURING AN IN-CLINIC FOLLOW-UP, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED FAILURE TO CAPTURE, FAILURE TO SENSE AND HIGH PACING IMPEDANCE. DIAGNOSTIC IMAGING WAS PERFORMED AND REVEALED THAT THE RV LEAD WAS FRACTURED. ON (B)(6) 2024, THE LEAD WAS PARTIALLY EXPLANTED, THE REST OF IT WAS CAPPED. THE LEAD WAS THEN REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992545 ↗
• InjuryJun 21, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED A PATIENT'S RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH OVERSENSING NOISE. THE LEAD WAS CAPPED AND REPLACED IN A PROCEDURE ON (B)(6) 2024. POST-PROCEDURE THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580147 ↗
• MalfunctionJun 18, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR LEAD EXHIBITED HIGH AND OUT OF RANGE DEFIBRILLATION IMPEDANCE. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559158 ↗
• InjuryJun 14, 2024Failure to Capture; High impedance; Device Sensing Problem; Failure to Capture; High impedance; Device Sensing Problem

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCE, SENSING VARIATION AND FAILURE TO CAPTURE. THE LEAD WAS CAPPED ON (B)(6) 2024 SUCCESSFULLY. THE PATIENT WAS STABLE AND ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537659 ↗
• MalfunctionMay 15, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT VIA REVIEW OF REMOTE TRANSMISSION, OVER-SENSING OF NOISE WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WERE NO ADVERSE HEALTH CONSEQUENCES, THE PATIENT WAS STABLE AND WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19319560 ↗
• InjuryMar 13, 2024Over-Sensing; Device Sensing Problem; Device Dislodged or Dislocated; Over-Sensing; Device Sensing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR IN-CLINIC FOLLOW UP. A DEVICE INTERROGATION REVEALED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED FALSE VENTRICULAR FIBRILLATION EPISODES, R -WAVE VARIABILITY, AND DOUBLE COUNTING DUE TO WIDE QRS COMPLEX. A SUBSEQUENT CHEST X-RAY REVEALED THAT THE LEAD WAS DISLODGED. THE PATIENT WAS SCHEDULED FOR REVISION AND THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899154 ↗
• InjuryJan 30, 2024Adverse 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'S IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) WAS EXTRACTED, DUE TO INFECTION. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 18611211 ↗
• InjuryDec 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-95640. IT WAS REPORTED A PATIENT'S RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS PRESENTED WITH DISLODGEMENT DUE TO TWIDDLER'S SYNDROME, CONFIRMED VIA X-RAY. LOSS OF LV CAPTURE WAS ALSO NOTED. THIS WAS ADDRESSED DURING A PROCEDURE ON (B)(6) 2023 IN WHICH THE LV LEAD WAS EXPLANTED AND REPLACED AND THE RV LEAD WAS REPOSITIONED. POST-PROCEDURE THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400972 ↗
• InjuryDec 13, 2023Break; Low impedance; Break; Low impedance

  IT WAS REPORTED THAT LOW DEFIBRILLATION IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN SUSPECTED LEAD DAMAGE, ALTHOUGH IT WAS NOT CONFIRMED. THE RV LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319495 ↗

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