Durata™ 7122Q-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 510 adverse event reports that list this exact device (DI 05414734503730), received between Jun 12, 2018 and Sep 10, 2026 — classified as 13 deaths, 353 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (144 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 510 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Signal Artifact/Noise

  It was reported that the patient's Right Ventricular (RV) lead exhibited noise. Further information was requested but not yet received.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716275 ↗
• InjuryAug 10, 2026Failure to Capture

  It was reported that the patient presented remotely via merlin.net. Review of transmission revealed that the right ventricular (RV) lead exhibited loss of capture. The RV lead was capped and replaced on (b)(6) 2026. The patient was in stable condition.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50195549 ↗
• InjuryJul 1, 2026Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A LEAD REVISION PROCEDURE. DEVICE INTERROGATION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLD AND LOSS OF CAPTURE. ON (B)(6) 2026, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE RV LEAD. IMAGING WAS PERFORMED DURING THE PROCEDURE, AND NO ABNORMALITIES WERE NOTED. THE PATIENT WAS DISCHARGED FOLLOWING THE PROCEDURE WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25684586 ↗
• InjuryMay 14, 2026Fracture; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED VIA MERLIN.NET AND WAS ASYMPTOMATIC. REVIEW OF THE TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING NOISE, RESULTING IN PACING INHIBITION AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING NOISE, RESULTING IN INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS). A FRACTURE WAS NOTED ON BOTH RA AND RV LEADS. THE PHYSICIAN ELECTED TO EXPLANT BOTH LEADS AND REPLACE THEM WITH NEW LEADS. THE PATIENT¿S CONDITION REMAINED STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25177584 ↗
• MalfunctionMay 13, 2026Over-Sensing

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING NOISE. THE LEAD WILL BE MONITORED. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160865 ↗
• InjuryApr 30, 2026Break; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGEOUT PROCEDURE. INTERROGATION REVEALED SEVERAL EVENTS OF NOISE RESULTING IN NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING EPISODES ON THE RIGHT VENTRICULAR (RV) LEAD. INSULATION BREACH OF THE RV LEAD WAS CONFIRMED VIA IMAGING. THE RV LEAD WAS CAPPED (B)(6) 2026 AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25052655 ↗
• MalfunctionApr 16, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED EPISODES OF NOISE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. NO INTERVENTION WAS REPORTED, AND THE PATIENT WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899025 ↗
• InjuryApr 7, 2026Therapy Delivered to Incorrect Body Area; Device Sensing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH EXTRACARDIAC STIMULATION. IT WAS OBSERVED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE DISLODGED AND SENSING NUMBERS ON BOTH LEADS WERE DOWN. THE RA LEAD WAS PROGRAMMED OFF TO PREVENT STIMULATION. BOTH THE RA AND RV LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS RECOVERING.

  Patient problems: Discomfort

  MAUDE report 24811994 ↗
• InjuryApr 4, 2026Over-Sensing; Capturing Problem

  IT WAS REPORTED THAT OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS CAPPED (B)(6) 2026, AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784546 ↗
• InjuryMar 24, 2026Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED DURING IN CLINIC FOLLOW UP THAT THE RIGHT VENTRICULAR LEAD DISPLAYED LOSS OF CAPTURE. X-RAY CONFIRMED DISLODGEMENT. THE PRODUCT WAS EXPLANTED AND SUCCESSFULLY REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674830 ↗
• MalfunctionMar 2, 2026Fracture; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE AND HIGH CAPTURE THRESHOLD. FRACTURE WAS NOTED ON THE RV LEAD. PROGRAMMING CHANGES WERE PERFORMED TO ADDRESS THE ISSUE, AND THE PATIENT WILL CONTINUE TO BE MONITORED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480374 ↗
• InjuryFeb 4, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION IMPEDANCE. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV LEAD. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE, AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24263276 ↗
• InjuryFeb 3, 2026Failure to Deliver Shock/Stimulation; Under-Sensing

  NEW INFORMATION RECEIVED NOTES THAT THE UNDER-SENSING EXHIBITED BY THE RIGHT VENTRICULAR (RV) LEAD RESULTED IN DELAY OF THERAPY. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS UNKNOWN.

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

  MAUDE report 24248799 ↗
• InjuryJan 8, 2026Signal Artifact/Noise; Break; Over-Sensing

  ADDITIONAL INFORMATION WAS RECEIVED THAT NOISE RESULTED IN OVERSENSING WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. PROVOCATIVE TESTING WAS PERFORMED, AND NOISE WAS NOT REPRODUCED. DIAGNOSTIC IMAGING WAS PERFORMED DURING THE REVISION PROCEDURE, PRIOR TO EXPLANT, AND LEAD DAMAGE WAS CONFIRMED. THE RV LEAD WAS EXPLANTED AND REPLACED TO RESOLVE EVENT. RV LEAD INSULATION DAMAGE WAS ALLEGED BUT WAS NOT CONFIRMED VISUALLY DUE TO PROCEDURAL DAMAGE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016305 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED WITH AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR, AND ATRIAL LEADS WERE EXPLANTED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 23853559 ↗
• InjuryDec 3, 2025Break; Over-Sensing; Break; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF THE TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED EPISODES OF OVER-SENSED NOISE. UPON REVIEW, IT WAS NOTED THAT THE LEAD EXHIBITED AN INSULATION BREACH. THE LEAD WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711466 ↗
• MalfunctionDec 2, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVER-SENSING. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700184 ↗
• InjuryNov 19, 2025High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. THE PATIENT ALSO PRESENTED AT THE EMERGENCY ROOM FOLLOWING A VENTRICULAR FIBRILLATION EPISODE FOR WHICH AN APPROPRIATE SHOCK WAS PROVIDED. IT WAS NOTED THAT HIGH PACING IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS CAPPED ON (B)(6) 2025 AND REPLACED WITH AN UPGRADE. THE PATIENT WAS STABLE WITH NO COMPLAINTS.

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

  MAUDE report 23600976 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A POSSIBLE INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED UNDERSENSING OF PATIENT ARRYTHMIA AND FAILED TO DELIVER SHOCK. PATIENT RECEIVED CARDIOPULMONARY RESUSCITATION AND IS CURRENTLY INTUBATED AND UNSTABLE. THE PHYSICIAN DID NOT INDICATE THAT INFECTION WAS RELATED TO ABBOTT DEVICE NOR PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 23584424 ↗
• MalfunctionNov 12, 2025Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIB IMPEDANCE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534313 ↗
• InjuryNov 11, 2025Failure to Capture; High impedance; Device Dislodged or Dislocated; Failure to Capture; High impedance; Device Dislodged or Dislocated

  AFTER INITIAL IMPLANT PROCEDURE, LOSS OF CAPTURE (LOC) AND HIGH IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. DIAGNOSTIC IMAGING WAS PERFORMED AND DISLODGEMENT WAS CONFIRMED. THE RV LEAD WAS REVISED TO RESOLVE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522024 ↗
• InjuryNov 6, 2025Inappropriate/Inadequate Shock/Stimulation; Low impedance; Capturing Problem; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Capturing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A VENTRICULAR TACHYCARDIA (VT) STORM AND WAS SHOCKED EXTERNALLY BY HEALTH CARE PROVIDERS. EXTERNAL PATCHES WERE PLACED DIRECTLY OVER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE PATIENT WAS SHOCKED EXTERNALLY AT LEAST 20 TIMES. THE ICD WAS NOT RESPONDING TO INTERROGATION AFTERWARDS. THE PHYSICIAN ASSUMES THE HIGH VOLTAGE SHOCK DEPLETED THE BATTERY AND/OR DAMAGED THE CIRCUITRY. THE RIGHT VENTRICULAR (RV) LEAD WAS TESTED, AND A LOW PACING IMPEDANCE, POOR SENSING AND A HIGH CAPTURE THRESHOLD WAS OBSERVED. RV LEAD DAMAGE WAS ALSO SUSPECTED. THE PATIENT'S ICD WAS EXPLANTED, AND THE RV LEAD WAS CAPPED ON (B)(6) 2025, AND BOTH WERE REPLACED. THE PATIENT WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 23493188 ↗
• InjurySep 18, 2025High impedance; Capturing Problem; High impedance; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT OF RANGE PACING IMPEDANCE AND HIGH CAPTURE THRESHOLD. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085621 ↗
• InjurySep 5, 2025Over-Sensing; Over-Sensing

  ADDITIONAL INFORMATION INDICATED THAT THE PATIENT PRESENTED REMOTELY. REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) EXHIBITED NOISE OVERSENSING. THE RV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986993 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN UNRELATED PROCEDURE, THE LEAD EXTRACTED RESULTED IN ONGOING BLOOD LOSS. THE BLEEDING WAS CONTROLLED BY REPAIRING THE ARTERY WITHOUT FURTHER ADVERSE PATIENT CONSEQUENCES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22906107 ↗

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