Durata™ 7120 (UDI 05414734502092)Recalls & reported problems

Summary

The FDA's MAUDE database contains 857 adverse event reports that list this exact device (DI 05414734502092), received between Jun 12, 2018 and Sep 29, 2026 — classified as 31 deaths, 459 injuries, 367 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (318 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 857 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941184 ↗
• MalfunctionSep 29, 2026Break; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936671 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented with vegetations on the leads. Lead vegetation was identified by transesophageal echocardiography (TEE). The physician did not believe the infection was device or procedure related. The entire system, including the Implantable Cardioverter Defibrillator (ICD), right ventricular lead, and right atrial lead, was explanted. The patient remained in stable condition.

  Patient problems: Unspecified Infection

  MAUDE report 50749860 ↗
• MalfunctionAug 20, 2026Over-Sensing

  During a remote follow-up, episodes of noise which resulted in myopotential oversensing were observed on the device. Provocative testing was performed and the noise was not reproduced. Technical Support was contacted and recommended reprogramming to resolve the event. No intervention has been performed at this time. The patient was stable and will continue to be monitored.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50334986 ↗
• MalfunctionAug 19, 2026High impedance

  It was reported that the patient presented remotely via Merlin.net. It was noted that the right ventricular (RV) lead and Implantable Cardioverter Defibrillator (ICD) exhibited high, out of range defibrillation impedance. No intervention was performed and the patient will continue to be monitored. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50329405 ↗
• InjuryAug 19, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient presented for in clinic follow-up. Device interrogation revealed that the Right Ventricular (RV) lead exhibited Post-Sensed T-wave Oversensing (PSTWOS) resulting in inappropriate shock and inappropriate Anti-Tachycardia Pacing (ATP). A Chest X-Ray was performed, and the physician suspected the Right Ventricular (RV) lead was interacting with a previously capped lead. Programming changes were performed to resolve the issue. The patient condition was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326099 ↗
• MalfunctionAug 14, 2026Break; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50257963 ↗
• MalfunctionJun 18, 2026High impedance

  DURING A REMOTE FOLLOW-UP, AN INCREASE IN DEFIBRILLATION IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. DIAGNOSTIC IMAGING WAS PERFORMED AND NO ABNORMALITIES WERE OBSERVED. REPROGRAMMING WAS PERFORMED TO RESOLVE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25554232 ↗
• InjuryJun 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SCHEDULED GENERATOR CHANGE. PRIOR TO THE GENERATOR CHANGE IT WAS DISCOVERED THAT THE DEVICE WAS PROGRAMMED TO AAIR; HOWEVER, IT IS UNKNOWN WHY THE DEVICE HAD A PROGRAMMING CHANGE. THE RIGHT VENTRICULAR LEAD WAS CAPPED AND REPLACED DURING THE GENERATOR CHANGE. THE PATIENT WAS DISCHARGED.

  Patient problems: Insufficient Information

  MAUDE report 25541856 ↗
• MalfunctionMay 29, 2026Over-Sensing

  IT WAS REPORTED THAT NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) DUE TO POST-SENSED T-WAVE OVERSENSING (PSTWOS) AND NOISE WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD. THE PATIENT DID NOT RECEIVE THERAPY DUE TO THE OVERSENSING. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT SYMPTOMS REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25339191 ↗
• MalfunctionMay 21, 2026Failure to Capture; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. A DEVICE INTERROGATION SHOWED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE PACING IMPEDANCE AND FAILURE TO CAPTURE. PROGRAMMING CHANGES WERE MADE TO DISABLE PACING AND HIGH VOLTAGE THERAPIES. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246714 ↗
• InjuryMay 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE EXPLANTED AND REPLACED FOR UNKNOWN REASON. DEBULKING WAS NOTED AS ONE OF THE REASONS FOR EXPLANT. THERE WAS NO OTHER INFORMATION AVAILABLE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211006 ↗
• MalfunctionApr 29, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE DEFIBRILLATION IMPEDANCE. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034870 ↗
• InjuryApr 13, 2026Break; High impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT SENSING NOISE WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE PACING IMPEDANCE HAD DECREASED, AND ON THE DAY OF THE EVENT, THE PACING IMPEDANCE MEASUREMENT WAS HIGH, OUT OF RANGE. INSULATION DAMAGE WAS SUSPECTED. AN X-RAY AND CT SCAN WERE PERFORMED. THE RV LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE EVENTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24861519 ↗
• InjuryApr 8, 2026Failure to Capture; Failure to Convert Rhythm

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH VENTRICULAR TACHYCARDIA (VT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD FAILED TO CONVERT THE PATIENT¿S RHYTHM AND EXTERNAL DEFIBRILLATION WAS USED. DEVICE INTERROGATION REVEALED THAT THE RV LEAD HAD FAILED TO CAPTURE. ON (B)(6) 2026, THE PHYSICIAN CAPPED AND REPLACED THE RV LEAD. DURING THIS PROCEDURE, FLUOROSCOPY WAS PERFORMED NOTING INSULATION BREAKS ON THE RIGHT ATRIAL (RA) LEAD. NO ANOMALIES WERE NOTED ON THE RV LEAD VIA FLUOROSCOPY. ADDITIONALLY, RA LEAD NOISE WAS NOTED DURING MANIPULATION. THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RA LEAD DURING THE SAME PROCEDURE. THE PATIENT CONDITION WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824007 ↗
• InjuryApr 6, 2026High impedance; Capturing Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED FOR AN ELECTIVE REPLACEMENT PROCEDURE. IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCE AND HIGH CAPTURE THRESHOLDS. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795035 ↗
• MalfunctionApr 3, 2026Failure to Capture; Over-Sensing

  NEW INFORMATION INDICATES THAT THE PATIENT PRESENTED TO THE CLINIC, AND PROGRAMMING CHANGES WERE MADE. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24783473 ↗
• MalfunctionMar 30, 2026Over-Sensing

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING NOISE THAT RESULTED IN PACING INHIBITION, WHICH WAS STORED AS NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) EPISODES. NOISE WAS PRESENT DURING ISOMETRIC TESTING. PROGRAMMING CHANGES WERE MADE, AND THE NOISE WAS NO LONGER PRESENT DURING REPEAT ISOMETRIC TESTING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24720960 ↗
• MalfunctionMar 25, 2026Low impedance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684005 ↗
• MalfunctionMar 18, 2026Break; High impedance

  DURING A FOLLOW-UP IN-CLINIC, AN INCREASE IN DEFIBRILLATION IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. RV LEAD DAMAGE WAS ALLEGED, BUT NOT CONFIRMED. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634225 ↗
• MalfunctionMar 16, 2026Fracture; High impedance; Stretched; Capturing Problem; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR FOLLOW UP. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD AND HIGH PACING IMPEDANCE. CHEST X-RAY CONFIRMED LEAD FRACTURE, STRETCHING, AND INSULATION WAS WORN. ADDITIONALLY, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALSO MIGRATED. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605990 ↗
• MalfunctionMar 6, 2026High impedance

  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 HIGH OUT-OF-RANGE DEFIBRILLATION IMPEDANCE. CHEST X-RAY WAS PERFORMED. NO CHANGES OR INTERVENTIONS WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539296 ↗
• InjuryMar 3, 2026Break; Low impedance

  ADDITIONAL INFORMATION WAS RECEIVED THAT RV LEAD DAMAGE WAS SUSPECTED BUT THIS WAS NOT CONFIRMED. THE RV LEAD VECTORS WERE CHANGED TO RESOLVE THIS EVENT, THE LEAD REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501860 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO TENDERNESS AT THE DEVICE POCKET SITE, ACCOMPANIED BY WOUND DEHISCENCE AND POCKET EROSION. THE PHYSICIAN EXPLANTED THE ENTIRE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR SYSTEM DUE TO INFECTION. THE PATIENT REMAINED IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 24471519 ↗
• InjuryFeb 26, 2026Break; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED NOISE. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE RIGHT ATRIAL LEAD HAD INSULATION DAMAGE AND HELIX RETRACTION ISSUES. THERE WAS ALSO DIFFICULTY TO ADVANCE AND FAILURE TO DISCONNECT FROM THE DEVICE. THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AND INSULATION DAMAGE. THE RIGHT ATRIAL LEAD WAS CAPPED AND REPLACED. THE RIGHT VENTRICULAR REMAINED IMPLANTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24461118 ↗

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