Durata™ 7121/75Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734502139), received between Jan 9, 2019 and Apr 14, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Fracture; Over-Sensing; Retraction Problem

  IT WAS REPORTED THAT THE PATIENT PRE-PROCEDURE EXHIBITED CHRONIC SYSTOLIC HEART FAILURE. IT WAS NOTED THAT NOISE CONSISTENT WITH A FRACTURE WAS SUSPECTED ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. DURING A PROCEDURE TO EXTRACT THE LEADS, THE HELICES COULD NOT BE RETRACTED. THE RA AND RV LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS DISCHARGED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24880118 ↗
• MalfunctionMay 2, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED NOISE ON THE RIGHT VENTRICULAR (RV) LEAD. NO CHANGES OR INTERVENTION WERE REPORTED. THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231398 ↗
• MalfunctionJan 9, 2021Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. REVIEW OF THE TRANSMISSION REVEALED THAT THE RIGHT VENTRICULAR LEAD HAD A LOW AND OUT-OF-RANGE DEFIBRILLATION IMPEDANCE IN ONE CONFIGURATION. THE DEVICE WAS REPROGRAMMED TO ADDRESS THE IMPEDANCE. NO OTHER ANOMALIES WERE REPORTED, AND THERE WERE NO REPORTED PATIENT SYMPTOMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11143571 ↗
• MalfunctionJan 9, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED OVERSENSING, LEADING TO INHIBITION OF PACING. PROGRAMMING CHANGES WERE DISCUSSED; HOWEVER, NO INTERVENTION WAS PERFORMED. THE PATIENT WAS ASYMPTOMATIC THROUGHOUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8232690 ↗

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