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Model/catalog/lot 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
Distribution dates: June 2001 to December 31, 2010 FDA Statement: 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.
The silicone insulation covering these models of Riata and Riata ST defibrillation 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.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.