The FDA notified healthcare professionals of a Class I Recall of the St. Jude Medical Riata and Riata ST Silicone
Endocardial Defibrillation Leads. The silicone insulation covering these leads is at risk of premature abrasion.
When abrasion occurs, the conductors inside the leads can come out (externalized) of the insulation. Leads with
externalized conductors may develop electrical dysfunction and not work as intended. In the event the device does
not work as intended, should a life-threatening heart rhythm occur, pacing or defibrillation therapy may not be
delivered as intended. This may result in serious adverse events, including death.
The recall includes the following model numbers:
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
On November 28, 2011, St. Jude Medical sent a Medical Device Advisory letter to physicians via certified mail.
The letter is an update to St. Jude Medical's Important Product Information letter, dated December 15, 2010. The
current Medical Device Advisory letter provides an update on the failure rates associated with externalized conductors
of Riata and Riata ST leads. The letter also includes updated recommendations and mitigations for patients implanted
with Riata and Riata ST leads.
Health care professionals are encouraged to report adverse events or side effects related to the use of these products
to the FDA's MedWatch Safety Information
and Adverse Event Reporting Program.
December 20, 2011 — FDA recall notice
