A Medical Device Daily
St. Jude Medical (St. Paul, Minneapolis) is removing certain defibrillator leads from the market over concerns that their electrical insulation could cause the devices to malfunction.
The medical device maker sent a letter to doctors saying that a newer version of leads, which have a different coating, already represent 97% of the market, The Wall Street Journal reported.
The company's Riata and Riata ST leads, which have silicon insulation, have a 0.47% 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 FDA 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.