On 14th December St. Jude Medical, Inc. announced that FDA has classified Riata and Riata ST defibrillation leads for class-I recall. U.S. Food and Drug Administration (FDA) has classified St. Jude’s voluntary medical device advisory letter to physicians from Nov. 28, 2011, which advised physicians to not use these leads as they are showing a higher rate of failure. The malfunctioning of either device or its leads causes critical complications and therefore the recall has been classified as Class-I.

The company has issued its advisory letter on 28th November, which was updated by FDA to follow the process of classification of the advisory letter issued by a device manufacturer to physicians on a medical device. The company has already dropped distribution of Riata and Riata ST ST silicon leads. It is estimated that around 80000 patients have Riata and Riata ST actively working in their body in United States. The  model affected by the recall are the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042).

This recall has been classified as class I by FDA because of the potential risk of serious injury or patient death due to malfunctioning of device. The advisory letter states that the clinical implications of externalized conductors in a defibrillation lead without electrical anomalies are not fully known or understood at present.  Externalized conductors can be seen as a visual observation on x-ray or fluoroscopy without any associated clinical or device-related observations. St. Jude Medical has reported two cases of deaths and one serious injury in patients, while extraction of a Riata lead with externalized conductors. One death and one serious injury case in patients with externalized conductors were also reported, though they were not attributed to externalized conductors.

St. Jude Medical asked patients to report any adverse event related to these leads or externalized conductors to the company’s Technical Services Department. It also asked to return leads, which have been extracted from patients. Company is ready to pay the cost and want these leads for further studying the reason of failure.  All reports received and returned devices received by St. Jude Medical of Riata leads are being reported to FDA as well.

Company agreed that all risks associated with these leads are not known yet. Patients who require frequent defibrillation or who are using pacemaker, are at higher risk of perforation. A Riata Leads Issue Seminar sponsored by the Heart Rhythm Society was scheduled on Dec. 21, 2011 and a Riata ICD Lead Summit sponsored by the Minneapolis Heart Institute Foundation scheduled on Jan. 20, 2012 to analyze the potential risks involved with these leads.

Company asked patients having leads that do not exhibit externalized conductors, to have continuous monitoring at regular scheduled visit intervals every three to six months.  It also asked patients having leads that exhibit externalized conductors with no electrical abnormality, to go for continuous monitoring of lead and system performance as per HRS/EHRA guidelines. Leads that exhibit externalized conductors with an associated electrical abnormality; patients should go for x-ray, fluoroscopy (cine), or additional testing.