St. Jude pulls defibrillator leads

December 16, 2010 by MassDevice staff

St. Jude Medical Inc. phases out its Riata and Riata ST leads for its defibrillators over malfunction concerns.

STJ logo

St. Jude Medical Inc. (NYSE:STJ) is removing certain defibrillator leads from the market over concerns that their electrical insulation could cause the devices to malfunction.

The St. Paul, Minn.-based medical device maker sent a letter to doctors yesterday saying that a newer version of leads, which have a different coating, already represent 97 percent of the market, The Wall Street Journal reported.

The company's Riata and Riata ST leads, which have silicon insulation, have a 0.47 percent rate of "insulation abrasion" over nine years of use, the company told doctors. The issue can cause an interruption in the cables' ability to sense rhythm problems in the heart, which could prevent needed shock therapy or even cause unwanted shocks to a patient's heart.

A St. Jude spokesperson said the Food & Drug Administration does not view the problem as a recall-worthy issue. The company is also not recommending that doctors remove the leads, which are implanted in a patients' heart through blood vessels, according to the WSJ.