St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads

Recall Class: Class I

Date Recall Initiated: November 28, 2011

Product(s): Riata and Riata ST Silicone Endocardial Defibrillation Leads

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

Use: The leads connect an implantable cardioverter defibrillator (lCD) or cardiac resynchronization therapy defibrillator (CRT-D) to cardiac tissue in order to monitor and regulate a patient’s heart rate by providing pacing and delivery of high voltage therapy for ventricular arrhythmias.

Recalling Firm:
St. Jude Medical
Cardiac Rhythm Management Division
15900 Valley View Court
Sylmar, CA 91342-3577

Reason for Recall: Failures associated with lead insulation abrasion on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads may cause the conductors to become externalized. If this occurs, this product may cause serious adverse health consequences, including death.

Public Contact:
Physicians with questions or concerns can contact their local St. Jude Medical representative or the Technical Services Department, available 24 hours a day, at 1-800-722-3774.

Consumers with questions can contact St. Jude Medical at 1-800-423-5611, 6:00 am – 5:00 pm, Pacific Time

FDA District: Los Angeles

FDA Comments: 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.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.