St Jude Stops Sales of CRT Leads With Possible Insulation Problem

Reed Miller


April 05, 2012

April 4, 2012 (St Paul, Minnesota) — St Jude Medical is warning physicians about a possible safety problem with some of its QuickSite and QuickFlex left-ventricular bipolar cardiac resynchronization therapy leads and is discontinuing sales of these models [1].

In a "dear doctor" letter, the company explains that it has reviewed 39 confirmed cases of externalized conductors on some models of QuickSite and QuickFlex due to abrasion of the silicone insulation in the distal portion of the lead [2]. Based on a review of returned leads and available fluoroscopic and X-ray images, the company believes this insulation abrasion problem may appear in 3% or 4% of QuickSite and QuickFlex leads. About 101 000 of these leads are in service worldwide, St Jude estimates.

The company has received no reports of death, serious injury, or electrical dysfunctions attributable to the externalized conductors, and some leads that have externalized conductors continue to function normally. However, "as a conservative measure," St Jude is immediately discontinuing sales of QuickSite and QuickFlex LV CRT leads models 1056T, 1058T, 1156T, and 1158T. The letter points out that the unipolar version of the QuickSite lead model 1056K, and the QuickFlex µ model 1258T and Quartet model 1458Q leads are not subject to this communication because they have a different construction with a different type of insulation.

This latest safety issue comes in the wake of new information about a short-circuit risk with St Jude's Riata and Riata ST (ICD) leads, as well as an earlier, much-discussed recall, which is also related to problems with the silicone insulation.