Durata™ 7121Q-65Recalls & reported problems

Summary

The FDA's MAUDE database contains 478 adverse event reports that list this exact device (DI 05414734503228), received between Jun 27, 2018 and Sep 29, 2026 — classified as 21 deaths, 269 injuries, 188 malfunctions.

The most frequently reported specific device problem is “High impedance” (152 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 478 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Break; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Charging Problem

  During a clinic follow-up, a decrease in the defibrillation and pacing impedance and episodes of noise resulting in oversensing and inappropriate anti-tachycardia pacing (ATP) were observed on the RV lead. Additionally, an Over Current Detection (OCD) alert was observed. RV lead damage was alleged, but was unable to be confirmed. Technical Support was contacted and the RV lead was capped and replaced to resolve the event. The patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932224 ↗
• MalfunctionJun 16, 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 INTERMITTENT OVERSENSING NOISE STORED AS NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) EPISODES. LEAD REVISION WAS DISCUSSED, NO CHANGES OR INTERVENTIONS WERE REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25526498 ↗
• MalfunctionApr 3, 2026High impedance

  IT WAS REPORTED THROUGH REMOTE TRANSMISSION 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 24780632 ↗
• InjuryMar 26, 2026Over-Sensing

  IT WAS REPORTED THAT PATIENT PRESENTED FOR SCHEDULED PROCEDURE. PRIOR TO PROCEDURE, IT WAS NOTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVER- SENSING NOISE. THE RV LEAD WAS CAPPED ON (B)(6) 2026 AND REPLACED WITH NEW LEAD. PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699453 ↗
• MalfunctionMar 25, 2026Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW, OUT-OF-RANGE DEFIBRILLATION IMPEDANCE. NO INTERVENTION WAS PERFORMED. THE PATIENT HAD NO ADVERSE CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688975 ↗
• MalfunctionMar 16, 2026Over-Sensing

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD DISPLAYED OVERSENSING DUE TO NOISE THAT RESULTED IN PACING INHIBITION. THE PRODUCT WAS EXPLANTED AND SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606874 ↗
• MalfunctionMar 5, 2026High impedance

  IT WAS REPORTED THAT, INCREASED DEFIBRILLATION IMPEDANCE WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD COIL WAS CHANGED BUT THIS WAS NOT SUCCESSFUL IN RESOLVING THIS EVENT. X- RAY IMAGING WAS PERFORMED; NO ANOMALIES WERE NOTED. DURING THE IN CLINIC FOLLOW UP, SHOCK TESTING WAS PERFORMED AND THE LEAD IMPEDANCE RETURNED TO NORMAL. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518748 ↗
• MalfunctionFeb 25, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING. NO INTERVENTION WAS PERFORMED. THE PATIENT HAD NO ADVERSE CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445819 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  NEW INFORMATION RECEIVED INDICATES THAT VEGETATION WAS PRESENT ON BOTH THE ATRIAL AND VENTRICULAR LEADS, AS WELL AS ON THE TRICUSPID VALVE, MITRAL VALVE, AND AORTIC VALVE. THE PRESENCE OF VEGETATION WAS CONFIRMED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM.

  Patient problems: Unspecified Infection

  MAUDE report 24267088 ↗
• InjuryFeb 3, 2026Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD. AN X-RAY WAS PERFORMED, AND NO CHANGES WERE NOTED. ON (B)(6) 2026, THE PHYSICIAN CAPPED AND REPLACED THE RV LEAD. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254041 ↗
• MalfunctionJan 21, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT INTERMITTENT OVERSENSING NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR LEAD. FURTHER INFORMATION WAS REQUESTED HOWEVER, WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24140176 ↗
• DeathJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2025 DUE TO PULSELESS ELECTRICAL ACTIVITY, DECOMPENSATED HEART FAILURE (HF), SUBDURAL HEMATOMAS, AND CHRONIC SYSTOLIC HF. IT IS UNKNOWN IF THE DEATH WAS DEVICE OR PROCEDURE RELATED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure/Congestive Heart Failure; Hematoma

  MAUDE report 23996684 ↗
• InjuryDec 30, 2025Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED UNDER-SENSING AND LOSS OF CAPTURE. LEAD REVISION OCCURRED ON (B)(6) 2025. THE LEAD WAS RENDERED INACTIVE AND SUCCESSFULLY REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23928000 ↗
• InjuryDec 18, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH OVER-SENSING OF NOISE NOTED ON THE PATIENT'S RIGHT VENTRICULAR LEAD, WHICH RESULTED IN INAPPROPRIATE SHOCKS. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846315 ↗
• MalfunctionDec 11, 2025Over-Sensing; Over-Sensing

  NEW INFORMATION RECEIVED NOTES NUMEROUS NON SUSTAINED OVERSENSING EPISODES WERE OBSERVED DUE TO RIGHT VENTRICULAR (RV) LEAD FAILURE. PROGRAMMING CHANGES FOR VENTRICULAR TACHYCARDIA/ FIBRILLATION (VT/VF) DETECTION WAS COMPLETED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783808 ↗
• MalfunctionNov 25, 2025High impedance; High impedance

  IT WAS REPORTED THAT HIGH VOLTAGE LEAD IMPEDANCE WAS OUT OF RANGE ABOVE THE UPPER LIMIT FOR VECTORS, INCLUDING THE SVC WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649962 ↗
• InjuryNov 14, 2025Failure to Deliver Shock/Stimulation; Fracture; Failure to Convert Rhythm; Failure to Deliver Shock/Stimulation; Fracture; Failure to Convert Rhythm

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE EPISODES OF VENTRICULAR FIBRILLATION (VF) AND VENTRICULAR TACHYCARDIA (VT). THE ARRHYTHMIAS WERE APPROPRIATELY DETECTED BY THE NON-ABBOTT DEVICE, HOWEVER, NO DEFIBRILLATION THERAPY WAS DELIVERED BY THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT EXPERIENCED PAIN, HOWEVER, THE ARRYTHMIAS SELF-TERMINATED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE DEVICE WAS REPLACED. HOWEVER, AFTER REPLACING THE DEVICE, VF TERMINATION WAS AGAIN NOT SUCCESSFUL. A LEAD FRACTURE WAS SUSPECTED, THEREFORE, THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia; Discomfort

  MAUDE report 23560079 ↗
• InjuryNov 4, 2025High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT TO THE LAB FOR A RIGHT VENTRICULAR (RV) LEAD EXPLANT. THE RV LEAD HAD EXHIBITED A RISE IN PACING IMPEDANCE AND A RISE IN THRESHOLD. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION WITH NO ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464290 ↗
• InjuryOct 31, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND RIGHT VENTRICULAR (RV) LEAD WAS CAPPED DUE TO INAPPROPRIATE SHOCK. THE PATIENT'S STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444338 ↗
• InjuryOct 29, 2025Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING RESULTING IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). ADDITIONALLY, FRACTURE WAS NOTED ON THE RV LEAD. PROGRAMMING CHANGES WERE PERFORMED TO ADDRESS THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417729 ↗
• InjuryAug 12, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP VIA MERLIN.NET. A REVIEW OF THE TRANSMISSION REVEALED EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) CAUSED BY NOISE EXHIBITED BY THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS SCHEDULED FOR REPLACEMENT AND THE LEAD WAS EXPLANTED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786645 ↗
• InjuryAug 6, 2025High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR THE REVISION OF THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025, DUE TO HIGH DEFIBRILLATION IMPEDANCE AND HIGH CAPTURE THRESHOLD. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726437 ↗
• InjuryJul 21, 2025High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A ROUTINE CHECK-UP. UPON INTERROGATION IT WAS NOTED THAT THE RIGHT-VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE AND HIGH CAPTURE THRESHOLDS AND THE RIGHT-ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING RESULTING IN INAPPROPRIATE AUTOMATIC MODE SWITCH. AS A RESOLUTION THE RV LEAD AND THE RA LEAD WERE EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560479 ↗
• MalfunctionJul 8, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH THE RIGHT-VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE. NO RESOLUTION WAS PERFORMED. THE PATIENT CONDITION WAS STABLE. THE PATIENT WOULD CONTINUE TO BE MONITORED REMOTELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22451002 ↗
• MalfunctionJul 8, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. DEVICE INTERROGATION REVEALED HIGH DEFIB IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. NO CHANGES OR INTERVENTIONS WERE PERFORMED. THE PATIENT WAS IN UNKNOWN CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22445516 ↗

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