Durata™ 7170Q-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 05414734503266), received between Jun 23, 2018 and Sep 16, 2026 — classified as 1 death, 68 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (29 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 97 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026High impedance; Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782388 ↗
• InjuryMar 13, 2026Low impedance; Charging Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING A SHOCK. DEVICE INTERROGATION REVEALED THAT THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) MISINTERPRETED THE ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE AS VENTRICULAR TACHYCARDIA AND DELIVERED AN INAPPROPRIATE SHOCK. IT WAS ALSO FOUND VIA INTERROGATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW DEFIBRILLATION IMPEDANCE AND AN OVER CURRENT DETECTION (OCD) ALERT. PROGRAMMING CHANGES WERE MADE, AND THE PATIENT¿S CONDITION REMAINED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597528 ↗
• InjuryDec 5, 2025Break; High impedance; Device Dislodged or Dislocated; Material Twisted/Bent; Break; High impedance; Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS NOTED THAT THE PATIENT'S RIGHT ATRIAL LEAD EXHIBITED NOISE AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE. DURING REPLACEMENT PROCEDURE, IT WAS DISCOVERED THAT THE RA AND RV LEADS WERE TWISTED IMPROPERLY AROUND THE DEVICE AND BOTH HAD INSULATION DAMAGE. THE RA AND RV LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730129 ↗
• MalfunctionAug 14, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT PATIENT PRESENTED FOR REMOTE FOLLOW-UP. REVIEW OF TRANSMISSION REVEALED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVER-SENSED NOISE. PROGRAMMING CHANGES WERE MADE. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812935 ↗
• MalfunctionJul 1, 2025High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCE AND HIGH CAPTURE THRESHOLD. THE LEAD WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373666 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL EXPERIENCING TENDERNESS DUE TO AN ABSCESS AT THE DEVICE POCKET SITE. THE PRESENCE OF MICROORGANISMS AT THE POCKET SIDE WAS FURTHER CONFIRMED WITH BIOPSY IN MICROBIOLOGY STUDY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED ON (B)(6) 2025 DUE TO THE INFECTION. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS UNRELATED TO ABBOTT DEVICE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 22288901 ↗
• MalfunctionJan 28, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED NOISE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. NO CHANGES OR INTERVENTIONS WERE PERFORMED THE DEVICE WILL CONTINUE TO BE MONITORED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21260821 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT PRESENTED FOR AN UPGRADE AND POCKET PUS WAS IDENTIFIED. THE SYSTEM WAS EXTRACTED IN A PROCEDURE ON 14 NOV 2024. POST-PROCEDURE THE PATIENT WAS STABLE.

  Patient problems: Unspecified Infection

  MAUDE report 20926435 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT PRESENTED IN THE CLINIC WITH RIGHT VENTRICULAR LEAD VEGETATION. AND INFECTION AT THE IMPLANTED DEVICE POCKET SITE. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM, IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD), RIGHT VENTRICULAR LEAD, LEFT VENTRICULAR LEAD AND ATRIAL LEAD, DUE TO INFECTION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 20197410 ↗
• InjuryJul 3, 2024Break; High impedance; Over-Sensing; Break; High impedance; Over-Sensing

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH OVER-SENSING OF NOISE AND HIGH PACING IMPEDANCE NOTED ON THE PATIENT'S RIGHT VENTRICULAR LEAD. IT WAS ALLEGED THAT THE ISSUES WERE DUE TO CLAVICLE CRUSH. THE LEAD WAS CAPPED AND REPALCED ON (B)(6) 2024. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669278 ↗
• InjuryMay 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH AN INFECTION AT THE IMPLANTED DEVICE POCKET SITE. IT WAS NOTED THAT THE VEGETATION WAS PRESENT IN THE RIGHT VENTRICLE LEAD. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM ¿ IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR, RIGHT VENTRICULAR LEAD, AND ATRIAL LEAD DUE TO INFECTION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 19398952 ↗
• InjuryMay 13, 2024Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  NEW INFORMATION RECEIVED NOTES THIS PATIENT RECEIVED A CARDIOMEMS (CARDIO MICRO-ELECTRO- MECHANICAL SYSTEM) IMPLANT ON 15 MAR 2024 WITH SUCCESSFUL CALIBRATION AND PHYSIOLOGIC READINGS. IT WAS NOTED ON 18 MAR 2024 THREE-DAY POST IMPLANT, THAT SENSOR READINGS COULD NOT BE OBTAINED FROM THE CARDIOMEMS IMPLANT. TROUBLE SHOOTING WAS PERFORMED WITH A REQUEST FOR ADDITIONAL IMAGING TO CONFIRM THE CARDIOMEMS SENSOR PLACEMENT. RIGHT VENTRICULAR WAVEFORMS WERE OBSERVED DURING THE READING. THE SENSOR WAS CONFIRMED DURING RADIOLOGY TO HAVE MIGRATED FROM THE LEFT PULMONARY ARTERY (PA) TO THE RIGHT VENTRICLE (RV) VIA FLUOROSCOPY. THE SITE PLANNED TO LEAVE THE SENSOR IN PLACE. ON 14 JUN 2024 THE PATIENT'S PACEMAKER LEADS WERE NOTED TO BE FAILING, AND THIS WAS BELIEVED TO BE RELATED TO THE CARDIOMEMS. ACCORDING TO THE PHYSICIAN, THE RIGHT VENTRICULAR (RV) LEAD WAS PICKING UP INAPPROPRIATE ECTOPY. THE SITE BELIEVED THE CARDIOMEMS SENSOR WAS LAYING ON THE RV LEAD. THE SITE WAS CONSIDERED EXTRACTION. ON 18 JUN 2024 AN ATTEMPT TO REMOVE THE CARDIOMEMS SENSOR WAS PERFORMED BUT WAS UNSUCCESSFUL. THE PHYSICIAN ELECTED TO ABORT THE REMOVAL OF THE SENSOR AND NO ISSUES OR HARM TO THE PATIENT WERE REPORTED.

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

  MAUDE report 19297891 ↗
• MalfunctionMar 6, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING FAILURE TO CAPTURE. NO CHANGES OR INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852918 ↗
• InjuryDec 18, 2023Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT'S RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH R-WAVE AMPLITUDE VARIATION AND HIGH CAPTURE THRESHOLDS DUE TO MICRO DISLODGEMENT. THE RV LEAD WAS EXPLANTED AND REPLACED IN A PROCEDURE ON (B)(6) 2023. POST-PROCEDURE THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352158 ↗
• InjuryDec 13, 2023Break; Over-Sensing; Break; Over-Sensing

  DURING A REMOTE FOLLOW UP, NOISE RESULTING IN OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS SUSPECTED THE LEAD WAS DAMAGED. THE RV LEAD WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. T HE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320534 ↗
• InjuryNov 7, 2023Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCK DUE TO THE NOISE OVERSENSING. NO INTERVENTIONS WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18087767 ↗
• MalfunctionOct 2, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING NOISE. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857963 ↗
• InjuryAug 29, 2023Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated

  NEW INFORMATION RECEIVED NOTES THE RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED. DETECTIONS WERE PROGRAMMED OFF PRIOR TO PROCEEDING WITH A PROCEDURE. THE RV LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO COMPLICATIONS AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646952 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 2017865-2023-38381. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SYNCOPE. IT WAS DISCOVERED THAT DISCHARGE AND BLOOD WAS COMING FROM THE DEVICE POCKET. DURING SYSTEM EXTRACTION, IT WAS DISCOVERED THAT THE POCKET SHOWED SIGNIFICANT NECROSIS AND THOUGH NO VEGETATION WAS NOTED ON THE RIGHT VENTRICULAR LEAD, ENDOCARDITIS WAS SUSPECTED. PATIENT WAS STABLE AND NOTED TO BE RECOVERING FOLLOWING PROCEDURE.

  Patient problems: Pocket Erosion; Syncope/Fainting; Unspecified Infection

  MAUDE report 17550983 ↗
• DeathJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-36615. IT WAS REPORTED THAT THE PATIENT DECEASED DUE TO ISCHEMIC HEART DISEASE. THERE WERE NO KNOWN ALLEGATIONS THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Ischemic Heart Disease

  MAUDE report 17386666 ↗
• MalfunctionJul 7, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED A PATIENT'S RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH FAR RIGHT OVERSENSING. NO CHANGES WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17283833 ↗
• InjuryJun 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. A DISLODGEMENT WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. ON (B)(6) 2023, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RV LEAD. THE PATIENT WAS IN UNKNOWN CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17127435 ↗
• InjuryApr 19, 2023Intermittent Capture; Device Dislodged or Dislocated; Insufficient Device Problem Information; Intermittent Capture; Device Dislodged or Dislocated; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH RIGHT VENTRICULAR (RV) LEAD FAILURE. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV LEAD. THE PATIENT CONDITION WAS NOT KNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770793 ↗
• InjuryMar 10, 2023High impedance; Over-Sensing; High impedance; Over-Sensing

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16523889 ↗
• InjuryDec 5, 2022Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A ROUTINE FOLLOW-UP ON 8(B)(6) 2022. UPON EXAMINATION OF THE LEAD, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH CAPTURE THRESHOLD. THE PHYSICIAN CAPPED AND REPLACED THE RV LEAD ON (B)(6) 2022. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15913053 ↗

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