Durata™ 7121Q-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 05414734503211), received between Nov 19, 2018 and Dec 3, 2025 — classified as 23 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (15 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025High impedance; High impedance

  IT WAS REPORTED THAT INTERMITTENT HIGH LEAD IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED VIA REVIEW OF REMOTE TRANSMISSION. THERE WERE INTERMITTENT OUT-OF-RANGE VALUES FOR THE RV TO SVC AND SVC TO CAN VECTORS WITHIN THE LAST 6 MONTHS. NO INTERVENTION WAS PERFORMED, AND NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709278 ↗
• InjuryDec 22, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICLE (RV) LEAD EXHIBITED HIGH PACING IMPEDANCES. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2023. THE PATIENT WAS IN STABLE CONDITION PRIOR TO AND POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387851 ↗
• InjuryJun 27, 2023Capturing Problem; Capturing Problem

  NEW INFORMATION RECEIVED INDICATED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXTRACTED AND REPLACED DUE TO ELEVATED CAPTURE THRESHOLDS. THAT PATIENT WAS ASYMPTOMATIC BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17209159 ↗
• InjuryMay 2, 2023Over-Sensing; Low impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD REVISION. IT WAS PREVIOUSLY NOTED THAT THE RV LEAD EXHIBITED NOISE OVER-SENSING AND LOW PACING IMPEDANCE AND THE RA LEAD EXHIBITED INAPPROPRIATE AUTOMATIC MODE SWITCH DUE TO NOISE OVER-SENSING. BOTH LEADS WERE CAPPED AND REPLACED ON (B)(6) 2023. PATIENT WAS EXPERIENCING LOW BLOOD PRESSURE DURING PROCEDURE. THE HYPOTENSION WAS RESOLVED, AND PATIENT CONDITION WAS STABLE POST PROCEDURE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 16850908 ↗
• MalfunctionApr 7, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING DUE TO NOISE. PROGRAMMING CHANGES WERE RECOMMENDED BUT NOT YET COMPLETED. THE PATIENT WAS STABLE AND ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16704197 ↗
• InjuryFeb 24, 2023Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT A PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED FAR P WAVE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD RESULTING IN INAPPROPRIATE THERAPY. NO CHANGES OR INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16434274 ↗
• MalfunctionFeb 14, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE. PROGRAMMING CHANGES WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375256 ↗
• InjuryDec 21, 2022Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED HIGH CAPTURE THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD. ON (B)(6) 2022, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RV LEAD. THE PATIENT WAS DISCHARGED FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16024819 ↗
• InjuryDec 21, 2022Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED DURING REMOTE FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD HAD DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING. THIS INAPPROPRIATE DEFIBRILLATION THERAPY WAS DUE TO OVERSENSING NOISE. PATIENT CONDITION WAS UNKNOWN. THE LEAD WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022982 ↗
• MalfunctionApr 20, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW UP VIA MERLIN.NET WITH A RIGHT VENTRICULAR LEAD THAT EXHIBITED NOISE OVER-SENSING. THE PATIENT WAS BROUGH IN TO THE CLINIC; PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164413 ↗
• MalfunctionApr 13, 2022Signal Artifact/Noise; Break; Signal Artifact/Noise; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE GENERATOR CHANGE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR LEAD HAD INSULATION DAMAGE. THE PHYSICIAN ELECTED TO REPAIR THE LEAD. THE PATIENT WAS IN STABLE CONDITION BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14107081 ↗
• InjuryJan 20, 2022Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LEAD FRACTURE, HIGH PACING IMPEDANCE, AND OVERSENSED NOISE WHICH LED TO INAPPROPRIATE SHOCK. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13309019 ↗
• InjuryDec 16, 2021Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE IN-PATIENT PRESENTED WITH INAPPROPRIATE THERAPY. THE RIGHT VENTRICULAR (RV) LEAD WAS OVER-SENSING NOISE CAUSING INAPPROPRIATE ANTI-TACHYCARDIA PACING. THE PHYSICIAN CAPPED AND REPLACED THE RV LEAD ON (B)(6) 2021. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020589 ↗
• MalfunctionNov 22, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA (B)(6). REVIEW OF THE TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING NOISE. PROGRAMMING CHANGES WERE PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858166 ↗
• MalfunctionNov 22, 2021Break; Break

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2021-37390. IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR HAD MIGRATED. IT WAS NOTED THAT THE DEVICE HAD ¿FALLEN¿ AND WAS BELOW THE LEFT BREAST. DURING THE SCHEDULED PROCEDURE, IT WAS OBSERVED THAT THE RIGHT VENTRICULAR LEAD HAD A MINOR INSULATION BREACH. THE DEVICE WAS EXPLANTED, AND THE PHYSICIAN ELECTED TO PUT SOME MEDICAL ADHESIVE OVER THE ABRASION. THE PATIENT WAS IN RECOVERING CONDITION POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858039 ↗
• InjuryNov 22, 2021Over-Sensing; Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT A PATIENT PRESENTED IN CLINIC FOR A FOLLOW-UP APPOINTMENT. THE PATIENT'S RIGHT VENTRICULAR (RV) WAS CAUSING EXTRACARDIAC STIMULATION AND OVERSENSING NOISE LEADING TO INAPPROPRIATE ATP. THE PATIENT WAS ASYMPTOMATIC. ON (B)(6) 2021, THE RV LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856199 ↗
• InjurySep 9, 2021Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) DUE TO DISCOMFORT FROM INAPPROPRIATE SHOCKS. IT WAS NOTED THIS ANOMALY WAS DUE TO THE RIGHT VENTRICULAR (RV) LEAD OVER-SENSING NOISE. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 12447651 ↗
• MalfunctionSep 8, 2021Degraded; High impedance; Degraded; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. DURING INTERROGATION, IT WAS OBSERVED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION LEAD IMPEDANCE, AND DEGRADATION. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443739 ↗
• MalfunctionJul 9, 2021Defective Device; Defective Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12144691 ↗
• InjuryJul 7, 2021Over-Sensing; Low impedance; Device Sensing Problem; Over-Sensing; Low impedance; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED LOW PACING IMPEDANCE AND R-WAVE AMPLITUDE VARIATION. NO CHANGES OR INTERVENTION WAS PERFORMED; THE PATIENT WOULD CONTINUE TO BE MONITORED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129836 ↗
• MalfunctionApr 13, 2021Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY TO THE CLINIC ON (B)(6) 2021. REVIEW OF TRANSMISSIONS REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD LOW DEFIBRILLATION LEAD IMPEDANCE. PHYSICIAN BROUGHT THE PATIENT IN CLINIC FOR A CHECK. DURING EXAMINATION OF RV LEAD, ALL THE FUNCTIONS WERE NORMAL AND THE LEAD DEFIBRILLATION IMPEDANCE WAS WITHIN RANGE. PHYSICIAN MADE PROGRAMMING CHANGES TO THE LEAD TO AVOID THIS ISSUE IN THE FUTURE. THE PATIENT WAS IN STABLE CONDITION BEFORE, DURING AND AFTER THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655686 ↗
• InjuryMar 30, 2021High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT WAS NOTIFIED VIA VIBRATORY ALERT ON AN UNKNOWN DATE OF AN EVENT OF HIGH DEFIBRILLATION IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. ON (B)(6) 2021 THE PHYSICIAN CAPPED AND REPLACED THE RV LEAD TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593233 ↗
• InjuryMar 29, 2021Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

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

  MAUDE report 11580574 ↗
• InjuryFeb 11, 2021High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ISSUE WAS DISCOVERED IN CLINIC FOR A FOLLOW UP. THE PATIENT'S PACING IMPEDANCE WAS ELEVATED. THE PATIENT WAS STABLE THROUGHOUT THE EXPLANT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11318459 ↗
• InjuryJan 25, 2021High impedance; High impedance

  IT WAS REPORTED THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCE. THE PATIENT PRESENTED IN CLINIC FOR A PROCEDURE ON (B)(6) 2021 WHERE THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11227383 ↗

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