Durata® 7130-60Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734505086), received between Mar 25, 2019 and Mar 20, 2022 — 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 16, 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.

• MalfunctionMar 20, 2022Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT A PATIENT PRESENTED IN A UNKNOWN MANNER, WITH LOSS OF CAPTURE NOTED ON THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD . NO INTERVENTION WAS REPORTED. NO PATIENT CONSEQUENCES OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13828222 ↗
• MalfunctionAug 5, 2021Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON INTERROGATION, IT WAS OBSERVED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285169 ↗
• InjuryDec 21, 2020Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR REVISION OF THE RIGHT VENTRICULAR LEAD DUE TO NOISE RESULTING IN OVER-SENSING. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2020. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11052132 ↗
• MalfunctionMar 25, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FEELING FUNNY. IT WAS NOTED THAT THE PATIENT HAD A RIGHT VENTRICULAR LEAD THAT WAS OVERSENSING. NO RESOLUTION WAS REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: Discomfort

  MAUDE report 8448223 ↗

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