Riata ICD Lead 'Alert' Is Now a Class I Recall

Disclosures

December 16, 2011

December 16, 2011 (St Paul, Minnesota) — The US FDA has classified a recent device advisory letter to physicians regarding the performance of St Jude Medical's Riata and Riata ST silicone endocardial defibrillation leads as a class I recall [1].

The classification--which is the agency's most serious designation and implies a potential risk of serious injury or patient death--relates to a medical device advisory letter issued to doctors on November 28, 2011, regarding the family of Riata and Riata ST leads, 79 000 of which are active in patients in the US.

The wires inside some leads can penetrate the insulation, resulting in inappropriate shocks, in some cases, and failure to deliver necessary shocks, in others. In the letter, the company said the number of leads affected by this problem had gone up by about a third, but remained under 1%. The company stopped selling the Riata leads a year ago.

The letter also states that the clinical implications of the faults are not fully known or understood at this time, but patients who require frequent defibrillation or who are pacemaker dependent may be at greater risk, it notes.

"At this time, no blanket statement can be made about clinical recommendations. Until more data are collected, physicians should follow standard of care to manage their patients with Riata silicone leads," Dr Anne Curtis (University of Buffalo, NY) said in a statement by St Jude [2].

Over the next few weeks, two public meetings to discuss Riata and associated clinical recommendations are scheduled: one sponsored by the Heart Rhythm Society on December 21, 2011, and a Riata ICD lead summit, sponsored by the Minneapolis Heart Institute on January 20, 2012.

Curtis is a member of St Jude Medical's advisory board.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....