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St. Jude Riata Endocardial Defibrillation Leads

Endocardial DefibrillationRecall Alert

The FDA has notified healthcare professionals of a Class 1 Recall of the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads.

The silicone insulation that covers these defibrillation leads is at risk of premature abrasion.  Meaning, when an abrasion occurs, the conductors inside the leads can come out of the insulation.  These leads could develop electrical dysfunction and not work properly.

If the device does not work as intended, and a serious heart rhythm occurs, serious adverse events could result, including death.

The recall includes the following:

  • Riata (8F) Silicone Endocardial Defibrillation Leads
    Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592
  • Riata ST (7Fr) Silicone Endocardial Defibrillation Leads
    Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042

If you have any questions or concerns about the St. Jude Riata Leads, call us at 800-888-8888.

Client Thanks

I would like to thank your firm for representing our family on behalf of my late husband. This whole process was, at times, difficult for us and sometimes painful. But, we were always in good hands as Brian and Maria are two of the hardest working and sincerest people I have ever had the pleasure of meeting. They did a tremendous job.

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