Durata™ 7170Q-52Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734503242), received between Aug 16, 2018 and Mar 21, 2022 — classified as 2 injuries.

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

• InjuryMar 21, 2022High impedance; High impedance

  RV LEAD 7170Q/52 (B)(4) WAS OBSERVED TO HAVE A >2500 OHM PACING IMPEDANCE AT GENERATOR REPLACEMENT. PHYSICIAN ELECTED CAP LEAD AND IMPLANT A NEW RV LEAD WHILE REPLACING GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840944 ↗
• InjuryAug 16, 2018High impedance; Over-Sensing; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS CAPPED DUE TO HIGH PACING IMPEDANCE. THE IMPEDANCE ISSUE WAS DISCOVERED 6 MONTHS PRIOR AND THE PHYSICIAN DECIDED TO MONITOR AND PERFORM THE SURGERY WHEN THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7789669 ↗

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