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Durata™ 7171Q-52Recalls & reported problems

St. Jude Medical, Inc. · Defibrillation Lead · Class 3 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734503273), received between Apr 9, 2021 and Apr 9, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Capturing Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Capturing Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 9, 2021Capturing Problem; Capturing Problem

    IT WAS REPORTED THAT THE PATIENT PRESENT FOR A BATTERY REPLACEMENT. UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR - RV LEAD EXHIBITED HIGH CAPTURE THRESHOLD. THE RV LEAD WAS CAPPED (B)(6) 2021 AND THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11643132 ↗

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

Other Permanent defibrillator electrodes devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.