Durata™ 7120Q-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,140 adverse event reports that list this exact device (DI 05414734503204), received between Jun 11, 2018 and Sep 16, 2026 — classified as 32 deaths, 709 injuries, 399 malfunctions.

The most frequently reported specific device problem is “High impedance” (296 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 1,140 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50796930 ↗
• MalfunctionSep 8, 2026Break; High impedance

  During a remote follow-up, there was increased defibrillation impedance in the right ventricular (RV) lead. Lead damage was suspected but not confirmed. The RV lead channel was reprogrammed to resolve the event. The patient is stable and will continue to be monitored.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50659911 ↗
• InjuryAug 31, 2026Fracture; High impedance; Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50520203 ↗
• InjuryAug 27, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient presented at the emergency room following several inappropriate shocks due to oversensing noise on the right ventricular (RV) lead. The RV lead was capped (b)(6) 2026, and replaced. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50476662 ↗
• MalfunctionAug 24, 2026Difficult to Fold, Unfold or Collapse

  During an initial implant procedure, the helix of the right ventricular (RV) lead repeatedly retracted on its own. The RV lead was explanted and replaced to resolve event. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410778 ↗
• MalfunctionAug 24, 2026Over-Sensing

  It was reported that a patient presented remotely via Merlin.net. Review of the transmission revealed that the patient's Right Ventricular (RV) lead exhibited Post-Paced T-wave Oversensing (PPTWOS). Programming changes were discussed, no changes or interventions were reported. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50399271 ↗
• InjuryAug 21, 2026Break; Over-Sensing; Low impedance

  It was reported that the patient was interrogated in the emergency room and multiple false ventricular tachycardia (VT) episodes were flagged. There were no inappropriate therapies noted, but insulation breach was suspected due to multiple noise episodes and low impedance on the right ventricular (RV) lead. The RV lead was explanted and replaced. The patient was discharged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50383927 ↗
• MalfunctionAug 14, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263026 ↗
• DeathAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient passed away due to cardiovascular disease. No further information was provided.

  Patient problems: Insufficient Information

  MAUDE report 50218178 ↗
• InjuryJul 6, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS ASYMPTOMATIC. IT WAS NOTED THAT THE PATIENT PRESENTED AT A HOSPITAL. IT WAS NOTED THAT OVERSENSING OF NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25719556 ↗
• InjuryJul 1, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING, RESULTING IN PACING INHIBITION. THE RV LEAD WAS CAPPED ON (B)(6) 2026 AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25684389 ↗
• MalfunctionJun 1, 2026High impedance

  IT WAS REPORTED THAT A HIGH PACING IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. NO OTHER ANOMALIES WERE REPORTED. THE PATIENT WAS SCHEDULED FOR A FUTURE APPOINTMENT IN CLINIC. THE PATIENT WAS BEING MONITORED REMOTELY. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351204 ↗
• InjuryMay 21, 2026High impedance

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD DISPLAYED HIGH DEFIBRILLATION IMPEDANCE. THE PRODUCT WAS CAPPED ON (B)(6) 2026 AND SUCCESSFULLY REPLACED. IMAGING WAS PERFORMED FOLLOWING PROCEDURE, BUT RESULTS WERE NOT PROVIDED. THE PATIENT WAS STABLE FOLLOWING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25245135 ↗
• MalfunctionMay 21, 2026Failure to Capture

  IT WAS REPORTED THAT T-WAVE OVERSENSING WAS OBSERVED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND IT WAS DETERMINED THAT THE T-WAVE OVERSENSING OCCURED DUE TO LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241180 ↗
• InjuryMay 20, 2026Capturing Problem

  DURING A REMOTE FOLLOW-UP, AN INCREASE IN CAPTURE THRESHOLD WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS CAPPED AND REPLACED TO RESOLVE EVENT. NO ABNORMALITIES WERE OBSERVED DURING THE REVISION PROCEDURE. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25232398 ↗
• MalfunctionMay 18, 2026Break; Over-Sensing; Low impedance

  DURING A REMOTE FOLLOW UP, NOISE RESULTING IN OVERSENSING AND DECREASED IMPEDANCE WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211869 ↗
• InjuryMay 11, 2026Failure to Convert Rhythm; Capturing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD AND FAILED TO CONVERT THE PATIENT¿S VENTRICULAR TACHYCARDIA (VT) REQUIRING MULTIPLE SHOCKS. ON (B)(6) 2026, THE PHYSICIAN EXPLANTED THE ICD AND CAPPED THE RV LEAD. THE ICD AND RV LEAD WERE REPLACED. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE.

  Patient problems: Arrhythmia

  MAUDE report 25144556 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR, THE RIGHT ATRIAL LEAD, THE RIGHT VENTRICULAR LEAD AND THE LEFT VENTRICULAR LEAD WERE EXPLANTED DUE TO INFECTION. THE PATIENT'S STATUS WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 24948361 ↗
• InjuryApr 11, 2026Capturing Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH CAPTURE THRESHOLD. THE RV LEAD WAS CAPPED ON (B)(6) 2026 AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852822 ↗
• InjuryMar 31, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD DELIVERED INAPPROPRIATE ANTITACHYCARDIA PACING (ATP) DUE TO NOISE OVERSENSING. NO INTERVENTION WAS PERFORMED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746448 ↗
• MalfunctionMar 31, 2026High impedance

  IT WAS REPORTED THAT AN ALERT OF HIGH VOLTAGE LEAD IMPEDANCE GREATER THAN THE UPPER LIMIT WAS SEEN DURING AN IN-CLINIC DEVICE CHECK ON THE RIGHT VENTRICULAR (RV) LEAD. A GRADUAL INCREASE WAS SEEN IN THE TREND. NO ADDITIONAL INFORMATION WAS PROVIDED, AND NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742875 ↗
• MalfunctionMar 26, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING AND MYOPOTENTIALS OVERSENSING. NO INTERVENTION WAS REPORTED. THE WERE NO PATIENT CONSEQUENCES NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701957 ↗
• MalfunctionMar 26, 2026Signal Artifact/Noise; Low impedance

  VOLUNTARY MEDWATCH RECEIVED STATES SIGNAL ARTIFACT AND LOW PACING IMPEDANCE NOTED ON THE RIGHT VENTRICULAR LEAD. THE LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701019 ↗
• InjuryMar 25, 2026Failure to Convert Rhythm; Low impedance; Charging Problem

  IT WAS REPORTED THAT THE THERE WAS LOW DEFIBRILLATION IMPEDANCE, OVER CURRENT DETECTION, AND INADEQUATE HIGH VOLTAGE OUTPUT WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS CAPPED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: Arrhythmia

  MAUDE report 24691898 ↗
• MalfunctionMar 19, 2026Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT PATIENT PRESENTED FOR SCHEDULED PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HELIX COULD NOT BE EXTENDED. THE LEAD WAS ULTIMATELY NOT USED AND REPLACED WITH NEW LEAD DURING THE SAME PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES AND PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641698 ↗

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