Durata™ 7121Q-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 529 adverse event reports that list this exact device (DI 05414734503167), received between Jun 11, 2018 and Sep 18, 2026 — classified as 27 deaths, 320 injuries, 182 malfunctions.

The most frequently reported specific device problem is “High impedance” (167 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 529 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Capturing Problem; Device Sensing Problem

  It was reported that the patient presented for an unrelated procedure. Device interrogation was performed prior to the procedure noting that the Right Ventricular (RV) lead exhibited high capture threshold and R-wave amplitude variation. On (b)(6) 2026, the physician capped and replaced the RV lead. Imaging was performed during the procedure and no anomalies were noted. The patient condition was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820023 ↗
• MalfunctionSep 8, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677000 ↗
• InjuryAug 26, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that during remote follow-up, the patient's right ventricular (RV) lead exhibited oversensing noise and resulted in the delivery of anti-tachycardia pacing (ATP). The noise could not be reproduced in the clinic. Lead revision was discussed, no changes or interventions were made. The patient's condition remained stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50455560 ↗
• MalfunctionAug 20, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358669 ↗
• InjuryAug 14, 2026Failure to Capture; High impedance

  It was reported during in clinic follow up that the right ventricular lead displayed increasing increase and a loss of capture. The lead was capped on (b)(6) 2026, and successfully replaced. There were no patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260033 ↗
• MalfunctionJun 19, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE. NO INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25568011 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR (RV), AND RIGHT ATRIAL (RA) LEAD. DURING PROCEDURE TO REMOVE THE SYSTEM, THE PATIENT BECAME HYPOTENSIVE AND A TRANSESOPHAGEAL ECHOCARDIOGRAM DISCOVERED THEY HAD PERICARDIAL EFFUSION. DRAINAGE WAS PERFORMED TO RESOLVE THE EFFUSION. THE PATIENT HAD TO BE RESUSCITATED WITH BLOOD. THE ICD, RV, AND RA LEAD WERE ALL EXPLANTED. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion; Unspecified Infection

  MAUDE report 25257653 ↗
• MalfunctionMay 21, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT WAS ASYMPTOMATIC. IT WAS NOTED THAT THE DEFIBRILLATORY IMPEDANCE WAS HIGH IN ALL CONFIGURATIONS ON THE RIGHT VENTRICULAR (RV) LEAD. ALL OTHER MEASUREMENTS WERE NORMAL. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS BEING MONITORED REMOTELY. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25248864 ↗
• MalfunctionMay 21, 2026High impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER AN IMPEDANCE ALERT VIA REMOTE MONITORING. HIGH-VOLTAGE IMPEDANCE (HVI) WAS LOW WITH A VERY HIGH RESISTANCE, WHILE THE OTHER VECTORS WERE FINE. PROGRAMMING CHANGES WERE MADE TO RESOLVE THE HVI ISSUES. THE PATIENT WAS IN STABLE CONDITION WITH NO ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25243687 ↗
• MalfunctionMay 17, 2026High impedance

  IT WAS REPORTED THAT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE. NO INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196174 ↗
• MalfunctionMay 1, 2026High impedance

  IT WAS REPORTED THAT THE SVC COIL IMPEDANCE WAS FOUND TO BE HIGH, OUT OF RANGE. THE DEVICE WAS REPROGRAMMED TO EXCLUDE SVC COIL FROM THE SHOCK CONFIGURATION. NO ADVERSE CLINICAL EFFECTS WERE NOTED, AND THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058870 ↗
• MalfunctionApr 27, 2026High impedance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008435 ↗
• InjuryMar 30, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  NEW INFORMATION RECEIVED INDICATES THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVER-SENSING RESULTING IN INAPPROPRIATE MODE SWITCH (AMS). THE PATIENT COMPLAINED OF DISCOMFORT DUE TO THE INAPPROPRIATE SHOCK BY THE RIGHT VENTRICULAR (RV) LEAD.

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

  MAUDE report 24725825 ↗
• InjuryMar 17, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  NEW INFORMATION INDICATES THAT THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED WITH A COMPETITOR LEAD ON (B)(6) 2026. NO COMPLICATIONS OR HEALTH CONSEQUENCES TO THE PATIENT WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618740 ↗
• MalfunctionMar 4, 2026Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) AND MULTIPLE VENTRICULAR TACHYCARDIA (VT) EPISODES WERE OBSERVED IN THE VENTRICULAR FIBRILLATION (VF) ZONE, PREMATURE VENTRICULAR CONTRACTIONS (PVC)S TRIGGERED TORSADES TREATED SUCCESSFULLY WITH SHOCK. THE EPISODE REPORT STATED THE SECURESENSE ALGORITHM INHIBITED THERAPY DUE TO NOISE ON THE RIGHT VENTRICULAR (RV) LEAD, BUT NO LEAD NOISE WAS LOGGED. THE NOISE ALSO COULD NOT BE REPRODUCED AND ALL IMPEDANCE DROPPED. THE PATIENT WAS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511207 ↗
• InjuryFeb 2, 2026Failure to Capture; High impedance; Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation; Low impedance

  IT WAS REPORTED THAT A PATIENT PRESENTED TO THE EMERGENCY ROOM WITH DISCOMFORT WITH INAPPROPRIATE SHOCK DUE TO INCORRECT INTERPRETATION OF SIGNAL. HIGH PACING IMPEDANCE AND LOW DEFIBRILLATION IMPEDANCE WAS NOTED. WHEN REASSESSED, THE PACING IMPEDANCE WAS STABLE. ADDITIONAL LOSS OF CAPTURE WAS NOTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL. NO ADDITIONAL INFORMATION REGARDING ADDITIONAL INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 24241535 ↗
• InjuryJan 15, 2026Failure to Capture; Under-Sensing

  VOLUNTARY MEDWATCH RECEIVED STATES UNDER-SENSING, FUNCTIONAL UNDER-SENSING, AND FAILURE TO CAPTURE WAS NOTED. THIS RESULTED IN SYNCOPE DIZZINESS AND ARRYTHMIA. NO FURTHER INFORMATION ON INTERVENTION OR ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Arrhythmia; Dizziness; Syncope/Fainting

  MAUDE report 24090222 ↗
• InjuryJan 15, 2026Signal Artifact/Noise

  NEW INFORMATION RECEIVED NOTED THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED (B)(6) 2026 AND REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 24086922 ↗
• MalfunctionJan 5, 2026Intermittent Capture; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT CAPTURE RESULTING IN OVERSENSING OF INTRINSIC R-WAVES. PROGRAMMING CHANGES WERE DISCUSSED, NO INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959055 ↗
• MalfunctionDec 22, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT NOISE OVERSENSING RESULTING IN PACING INHIBITION WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866196 ↗
• InjuryDec 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS, DISCHARGED AND SKIN EROSION THAT RESULTING IN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) ERODED. THE SOURCE OF THE INFECTION APPEARED TO BE A THROMBIX NON-ABSORBABLE PAD LEFT IN THE POCKET AT THE INITIAL IMPLANT AND NOT RELATED TO THE ABBOTT PRODUCTS. THE ICD, RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED DUE TO THE INFECTION. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Unspecified Infection

  MAUDE report 23861325 ↗
• MalfunctionDec 16, 2025Over-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 23817498 ↗
• MalfunctionNov 17, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED OVERSENSING NOISE AND FALSE AUTOMATIVE MODE SWITCH AND THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING NOISE. EPISODES WERE REPRODUCIBLE WITH UPPER BODY MOVEMENTS. NO INTERVENTION WAS PERFORMED. THE CLINIC DECIDED TO CONTINUE TO MONITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576512 ↗
• InjuryNov 10, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING. NO INTERVENTION WAS PERFORMED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23516935 ↗
• MalfunctionNov 7, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE HIGH VOLTAGE (HV) LEAD IMPEDANCE WAS HIGH AND OUT OF RANGE ON THE RIGHT VENTRICULAR (RV) LEAD. PROGRAMMING CHANGES WERE RECOMMENDED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23503203 ↗

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