Durata™ 7122 (UDI 05414734502146)Recalls & reported problems

Summary

The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 05414734502146), received between Jun 19, 2018 and Sep 1, 2026 — classified as 7 deaths, 100 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (49 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 168 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that a patient presented remotely via Merlin.net. Review of the transmission revealed that the patient's Right Ventricular (RV) lead delivered an inappropriate shock. Oversensing noise due to electromagnetic interference (EMI) was suspected to be the cause of the inappropriate shock. No changes or interventions were reported. The patient condition was not known.

  Patient problems: Discomfort

  MAUDE report 50554191 ↗
• InjuryJun 3, 2026High impedance; Over-Sensing

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVER-SENSING NOISE AND HIGH PACING IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2026. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374431 ↗
• MalfunctionMay 19, 2026Over-Sensing

  IT WAS REPORTED THAT THERE WAS OVERSENSING NOISE OBSERVED ON THE RIGHT VENTRICULAR LEAD. PROGRAMMING CHANGES WERE PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25223925 ↗
• MalfunctionMay 12, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD VIA A REVIEW OF REMOTE TRANSMISSION. THE PATIENT PRESENTED TO THE CLINIC, AND NO NOISE WAS REPRODUCED. NO CHANGES WERE MADE. THE PATIENT WAS ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153498 ↗
• InjuryJan 30, 2026Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE OVERSENSING RESULTING IN INAPPROPRIATE SHOCK. RV LEAD FRACTURE WAS 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 24228912 ↗
• InjuryJan 22, 2026High impedance; Under-Sensing

  RV LEAD (EPICARDIALLY IMPLANTED) RECORDED MULTIPLE OUT OF RANGE ABOVE UPPER THRESHOLD LOW VOLTAGE IMPEDANCE MEASUREMENTS. THESE INSTANCES BEGAN INCREASING IN FREQUENCY AND INTERMITTENT UNDER SENSING WAS NOTED. HIGH VOLTAGE IMPEDANCE WAS NORMAL. THE DECISION WAS MADE TO REPLACE THE RV LEAD. HOWEVER, BECAUSE THE ENTIRE ICD SYSTEM WAS EPICARDIAL, A NEW DUAL CHAMBER ICD SYSTEM WAS IMPLANTED WITHOUT ISSUE. THE OLD SYSTEM WAS TURNED OFF AND ABANDONED IN THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24149053 ↗
• MalfunctionJan 9, 2026Under-Sensing

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. NO INTERVENTION WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED AND NOT RECEIVED. THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023699 ↗
• MalfunctionDec 16, 2025Signal Artifact/Noise; Failure to Capture; Signal Artifact/Noise; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC. A DEVICE INTERROGATION WAS PERFORMED AND FOUND THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED FAILURE TO CAPTURE AND NOISE. NO INTERVENTION WAS PERFORMED. THE PATIENT HAD NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817130 ↗
• MalfunctionNov 10, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR REMOTE FOLLOW UP VIA MERLIN.NET. A REVIEW OF THE TRANSMISSION SHOWED ELEVATED DEFIBRILLATION IMPEDANCE EXHIBITED BY THE RIGHT VENTRICULAR (RV) LEAD. NO INTERVENTIONS WERE MADE, AND THE ISSUE WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513193 ↗
• InjurySep 19, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT'S CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098873 ↗
• InjurySep 5, 2025Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Capturing Problem; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Capturing Problem

  NEW INFORMATION RECEIVED INDICATES THAT INITIALLY THE PATIENT PRESENTED VIA REMOTE TRANSMISSION. THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED AND EXHIBITED NOISE OVERSENSING. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22986483 ↗
• InjurySep 2, 2025Over-Sensing; Low impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT UNSPECIFIED OVERSENSING AND LOW PACING IMPEDANCE WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS CAPPED AND REPLACED ON 13 AUG 2025. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22946022 ↗
• MalfunctionJul 24, 2025High impedance; High impedance

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH HIGH DEFIBRILLATION IMPEDANCE NOTED ON THE PATIENT'S RIGHT VENTRICULAR LEAD. THE CHANGE WAS SUSPECTED TO THE DUE TO A PHYSIOLOGIC CHANGE. THE LEAD WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591505 ↗
• InjuryJun 26, 2025Over-Sensing; Failure to Advance; Over-Sensing; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT WAS NOT PACER DEPENDENT. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO CAPTURE, NO SENSING AND WAS FOUND TO HAVE DISLODGED DUE TO TWIDDLER'S AND OVERSENSING WAS PRESENT ON THE RIGHT VENTRICULAR (RV) LEAD. A PROCEDURE WAS PERFORMED WHEREBY THE RA LEAD WAS EXTRACTED WITH THE GENERATOR AND AN ATTEMPT TO EXTRACT THE RV LEAD WAS ABORTED AS THE PHYSICIAN DID NOT HAVE THE PROPER TOOLS. THERE WAS NO COMPLAINT ON THE GENERATOR. THE PATIENT WAS BROUGHT BACK IN A FEW DAYS LATER ON (B)(6) 2025, FOR A PROCEDURE TO EXTRACT THE RV LEAD. THE PHYSICIAN ATTEMPTED TO INSERT A STYLET THROUGH THE RV LEAD BUT WAS UNABLE TO ADVANCE IT PAST THE CONNECTOR PIN. THE RV LEAD WAS CUT, EXTRACTED, AND A NEW SYSTEM WAS IMPLANTED. THE PATIENT WAS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342140 ↗
• InjuryJun 2, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED PRIOR TO THE PROCEDURE. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE IMPLANTED RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVER-SENSING RESULTING IN PACING INHIBITION. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD SHOWED HIGH CAPTURE THRESHOLD. THE RA AND RV LEADS WERE CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122889 ↗
• InjuryMay 30, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM IN COMPLETE HEART BLOCK. A DEVICE INTERROGATION REVEALED RECORDED EPISODES OF NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO) AND PACING INHIBITION. THE EPISODES WERE A RESULT OF 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: Arrhythmia

  MAUDE report 22114843 ↗
• DeathApr 3, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH VOLTAGE (HV) IMPEDANCE ANOMALY. ON (B)(6)2025, THE PATIENT PRESENTED TO THE HOSPITAL TO EXTRACT THE RIGHT ATRIAL (RA) AND RV LEADS. DURING THE PROCEDURE, THE SUPERIOR VENA CAVA (SVC) WAS OCCLUDED AND THE PHYSICIAN WAS ONLY ABLE TO EXTRACT THAT RA LEAD AND A PORTION OF THE RV LEAD. THE PHYSICIAN DECIDED TO IMPLANT AN ATRIAL LEADLESS PACEMAKER (LP). THE LP IMPLANT WAS SUCCESSFUL, HOWEVER, AFTER AN HOUR THE PATIENT'S BLOOD PRESSURE DROPPED AND THE PATIENT 'CODED.' THE PATIENT WAS TREATED WITH ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) AND LATER PUT ON LIFE SUPPORT. IT WAS NOTED THAT THERE WAS AN EFFUSION AT THE RIGHT ATRIUM AND INFERIOR VENA CAVA (IVC) JUNCTION. THE PHYSICIAN SUSPECTED THAT THIS WAS CAUSED BY LEAD EXTRACTION FROM THE GROIN. THE PATIENT WAS REMOVED FROM LIFE SUPPORT A FEW DAYS AFTER.

  Patient problems: Arrhythmia; Cardiac Perforation; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 21764064 ↗
• DeathMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-28083. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-28084. IT WAS REPORTED THAT THE PATIENT HAS DECEASED. THE PATIENT EXPERIENCED A SUDDEN SHOCK IN THE CHEST AND LOW BLOOD PRESSURE. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Discomfort; Low Blood Pressure/ Hypotension

  MAUDE report 21667486 ↗
• InjuryMar 17, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT A PATIENT PRESENTED TO CLINIC FOR FOLLOW UP. DEVICE INTERROGATION REVEALED LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV LEAD. THE PATIENT CONDITION WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21626435 ↗
• InjuryMar 7, 2025Failure to Convert Rhythm; Failure to Convert Rhythm

  RELATED REFERENCE REPORT NUMBER: 2017865-2025-17006. IT WAS REPORTED THAT FAILURE TO CONVERT RHYTHM WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE ICD. THE PATIENT CONDITION WAS STABLE.

  Patient problems: Arrhythmia

  MAUDE report 21554649 ↗
• MalfunctionJan 28, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED A PATIENT'S RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH OVER-SENSING NOISE. NO CHANGES WERE REPORTED. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21259978 ↗
• MalfunctionJan 1, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED PRIOR TO GENERATOR EXCHANGE THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. THE LEAD WILL CONTINUE TO BE MONITORED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21051434 ↗
• InjuryNov 21, 2024High impedance; High impedance

  IT WAS REPORTED, THAT THE PATIENT PRESENTED AT THE EMERGENCY ROOM, AFTER RECEIVING A VIBRATORY NOTIFICATION. IT WAS NOTED, THAT A HIGH PACING IMPEDANCE WAS OBSERVED, ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754721 ↗
• MalfunctionNov 17, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED, DURING REMOTE FOLLOW UP. THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED OVERSENSING NOISE. NO INTERVENTION OR PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20702647 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PRODUCT RECEIPT THAT THE PATIENT HAD DEVELOPED INFECTION WITH NO ALLEGATION OF IT BEING PROCEDURE OR PRODUCT RELATED, EXCEPT FOR A "POOR POCKET." THE WHOLE SYSTEM INCLUDING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT VENTRICULAR LEAD, RIGHT ATRIAL LEAD, LEFT VENTRICULAR LEAD, AND LEFT BUNDLE LEAD, WAS EXPLANTED AND REPLACED WITH A TEMPORARY PACEMAKER SYSTEM. PATIENT CONDITION WAS STABLE THROUGHOUT.

  Patient problems: Unspecified Infection

  MAUDE report 20404020 ↗

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