Durata™ 7120Q-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 289 adverse event reports that list this exact device (DI 05414734503037), received between Jun 22, 2018 and Sep 18, 2026 — classified as 11 deaths, 173 injuries, 105 malfunctions.

The most frequently reported specific device problem is “High impedance” (82 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 289 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Over-Sensing

  It was reported during in clinic follow up that the right ventricular lead displayed oversensing. The left ventricular lead reportedly exhibited an unspecified product performance issue. Both products were capped on (b)(6) 2026 and successfully replaced. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828768 ↗
• InjuryAug 28, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient's Right Ventricular (RV) lead delivered an inappropriate shock. Further information was requested but not yet received.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50506036 ↗
• MalfunctionMay 1, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE. 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 25062203 ↗
• InjuryApr 24, 2026High impedance; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE AND HIGH CAPTURE THRESHOLD. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD FAILED TO CAPTURE. FLUOROSCOPY WAS PERFORMED, NOTING LV LEAD FRACTURE. NO ABNORMALITIES WERE NOTED ON THE RV LEAD VIA FLUOROSCOPY. PROGRAMMING CHANGES WERE PREVIOUSLY MADE TO RESOLVE THE HIGH CAPTURE THRESHOLD ISSUE ON THE RV LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV AND LV LEADS. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24986819 ↗
• MalfunctionApr 13, 2026High impedance

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD DISPLAYED HIGH DEFIBRILLATION IMPEDANCE. THE PRODUCT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853829 ↗
• InjuryApr 1, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A RIGHT VENTRICULAR (RV) LEAD REVISION. REVIEW OF THE ELECTROGRAM (EGM) REVEALED OVERSENSING NOISE ON THE RV LEAD, WHICH WAS STORED AS NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) EPISODES. ON (B)(6) 2026, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RV LEAD. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761184 ↗
• InjuryDec 16, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW DEFIBRILLATION IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817907 ↗
• InjuryDec 8, 2025Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT INAPPROPRIATE SHOCKS WERE DELIVERED DUE TO RIGHT VENTRICULAR (RV) LEAD DISLODGEMENT. AN X-RAY WAS PERFORMED TO CONFIRM THE DISLODGEMENT. THE PHYSICIAN EXPLANTED THE RV LEAD. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750279 ↗
• InjuryNov 24, 2025Over-Sensing; Low impedance; Impedance Problem; Over-Sensing; Low impedance; Impedance Problem

  NEW INFORMATION RECEIVED INDICATES THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW, OUT OF RANGE PACING IMPEDANCE. THE PATIENT REMAINED STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638413 ↗
• InjuryNov 11, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED PRIOR TO THE SCHEDULED LEFT VENTRICULAR LEAD (LV) REPLACEMENT PROCEDURE. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE IMPLANTED RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD. THE RV LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524433 ↗
• InjuryNov 7, 2025Failure to Capture; High impedance; Device Sensing Problem; Failure to Capture; High impedance; Device Sensing Problem

  IT WAS REPORTED THAT TESTING WAS PERFORMED THE NEXT DAY AFTER THE PROCEDURE AND UPON REVIEW, IT WAS DISCOVERED THAT THE RIGHT VENTRICULAR LEAD (RV) EXHIBITED LOW R-WAVES, A RISE IN IMPEDANCE AND AN INABILITY TO CAPTURE. AN X-RAY WAS PERFORMED, AND THE RESULTS DID NOT SHOW THE RV LEAD DISLODGED. THE LEAD WAS SUCCESSFULLY REPOSITIONED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501562 ↗
• InjurySep 17, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT DURING AN IN-CLINIC FOLLOW-UP, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED EPISODES OF OVER-SENSED NOISE. THE NOISE WAS NOT REPRODUCED. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074791 ↗
• InjuryJun 7, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR LEAD EXHIBITED NOISE OVERSENSING CAUSING INCORRECT DETERMINATION OF VENTRICULAR FIBRILLATION, RESULTING IN INAPPROPRIATE SHOCK. NO INTERVENTION WAS PERFORMED. THE PATIENT EXPERIENCED NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22162923 ↗
• MalfunctionMay 12, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT NOISE OVERSENSING DUE TO SUSPECTED ELECTROMAGNETIC INTERFERENCE (EMI) WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. NO CHANGES OR INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004019 ↗
• MalfunctionApr 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT VIA A REVIEW OF REMOTE TRANSMISSION, AN ALERT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, HIGH VOLTAGE (HV) LEAD IMPEDANCE ABOVE THE UPPER LIMIT. LEAD INTEGRITY CHECK AND PROGRAMMING CHANGES WERE DISCUSSED. NO INTERVENTION AND NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881893 ↗
• InjuryApr 3, 2025Difficult to Fold, Unfold or Collapse; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated; Difficult to Fold, Unfold or Collapse; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP WITH OVER-SENSING EXHIBITED BY THE RIGHT VENTRICULAR (RV) LEAD. NO INTERVENTIONS WERE REPORTED. THE PATIENT WAS STABLE.

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

  MAUDE report 21763897 ↗
• InjuryMar 11, 2025Use of Device Problem; Capturing Problem; Device Dislodged or Dislocated; Use of Device Problem; Capturing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT PRESENTED FOR A GENERATOR UPGRADE. PRIOR TO THE PROCEDURE, DEVICE INTERROGATION REVEALED HIGH CAPTURE THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD. X-RAY WAS PERFORMED AND REVEALED LACK OF LEAD SLACK AND MICRO-DISLODGEMENT OF THE RV LEAD. ON (B)(6) 2025, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RV LEAD. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21580394 ↗
• InjuryFeb 21, 2025Failure to Capture; Fracture; Failure to Capture; Fracture

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH LOSS OF CAPTURE ON THE RIGHT VENTRICULAR LEAD. THE PHYSICIAN ALLEGED THIS WAS DUE TO LEAD FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2025. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434106 ↗
• InjuryJan 31, 2025Fracture; High impedance; Capturing Problem; Fracture; High impedance; Capturing Problem

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED CAPTURE AND IMPEDANCE VALUE. POSSIBLE LEAD FRACTURE WAS SUSPECTED. THE LEAD WILL BE MONITORED. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282938 ↗
• MalfunctionJan 15, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP WITH EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) RECORDED BY THE DEVICE. THE EPISODES WERE CAUSED BY LOSS OF CAPTURE EXHIBITED BY THE RIGHT VENTRICULAR LEAD. THE PATIENT WAS SICK AND HOSPITALIZED. A REVIEW OF DEVICE RECORDS FOUND THAT A RECENT CAPTURE TEST SHOWED NO RIGHT VENTRICULAR (RV) LEAD CAPTURE ISSUES, AND THE ISSUE WAS ATTRIBUTED TO PATIENT CONDITION. NO PATIENT SYMPTOMS WERE REPORTED. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162369 ↗
• MalfunctionJan 2, 2025High impedance; Over-Sensing; Capturing Problem; High impedance; Over-Sensing; Capturing Problem

  IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD, HIGH PACING IMPEDANCE AND NOISE OVERSENSING. NO INTERVENTION WAS DONE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060224 ↗
• InjuryOct 21, 2024Failure to Capture; Difficult to Fold, Unfold or Collapse; Failure to Capture; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH CAPTURE THRESHOLDS WHICH LED TO LOSS OF CAPTURE. THE PATIENT WAS ASYMPTOMATIC. DURING THE PROCEDURE, THE PHYSICIAN ELECTED TO REPOSITION THE LEAD TO DISCERN WHETHER THIS WOULD RESOLVE THE ISSUE OF HIGH CAPTURE THRESHOLDS, BUT THE HELIX OF THE RV LEAD FAILED TO EXTEND. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493596 ↗
• InjuryOct 17, 2024Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH HIGH IMPEDANCE AND LOSS OF CAPTURE NOTED ON THE PATIENT¿S RIGHT VENTRICULAR LEAD. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2024. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20476909 ↗
• MalfunctionOct 17, 2024High impedance; High impedance

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH HIGH DEFIBRILLATION IMPEDANCE NOTED ON THE RIGHT VENTRICULAR LEAD. NO INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20473041 ↗
• InjurySep 18, 2024Failure to Capture; Device Sensing Problem; Device Dislodged or Dislocated; Failure to Capture; Device Sensing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A LEAD REVISION PROCEDURE TO CORRECT THE LEAD DISLODGEMENT DUE TO TWIDDLER AND THE LEAD EXHIBIT FAILURE TO CAPTURE AND IMPROPER SENSING. BESIDES, IT WAS NOTED THAT THE DEVICE HAD MIGRATED AND EXHIBITED FAILURE TO CAPTURE AND IMPROPER SENSING. THE INFECTION WAS NOTED ONCE THE POCKET WAS OPEN. THE ENTIRE GALLANT SYSTEM INCLUDING THE RIGHT ATRIAL LEAD AND THE RIGHT VENTRICULAR LEAD WERE EXPLANTED DUE TO POCKET INFECTION, THERE WAS NO ALLEGATION OF INFECTION BEING DEVICE OR PROCEDURE RELATED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 20243974 ↗

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