CardioGen-82 Legal News Articles & Interviews

Princeton, NJ A year after the CardioGen-82 recall was announced, Bracco Diagnostics announced that the CardioGen-82 received clearance to be reintroduced. When the CardioGen-82 PET recall was announced, the US Food and Drug Administration (FDA) indicated that there were some deficiencies with the generator, however more recent reports suggest the problem was with how the generator was used. Either way, it is vital that with the CardioGen-82 being reintroduced that steps are taken to ensure patients are safe.

Washington, DC It may be funny to see poor, hapless Homer Simpson bringing the Springfield nuclear power plant to a boil and glowing green as a result, but when two CardioGen-82 heart patients set off airport security scanners after undergoing nuclear testing, the fallout is anything but humorous.

Las Vegas, NV Katie had a CardioGen-82 PET Scan in March 2011 for a heart issue—results came back negative. But in July her doctor called: they wanted to talk about the PET Scan. More specifically, possible CardioGen-82 radiation exposure.

Washington, DC Following the announcement that patients receiving an injection of chemicals generated by the CardioGen-82 may be at risk of receiving an increased PET radiation dose, the US Food and Drug Administration (FDA) has announced that the problem may be related to how the CardioGen-82 is administered and not due to manufacturing deficiencies. Although the FDA initially announced concern about manufacturing procedures, which prompted the CardioGen-82 recall by Bracco Diagnostics, the agency has now said the deficiencies do not appear to have caused the excess radiation in some patients.

Washington, DC Pulled from the market in July of last year, a nuclear perfusion agent is on its way back, according to a March release from States News Service (3/6/12). CardioGen-82 will be making a return appearance to the marketplace accompanied by a black box warning with regard to radiation levels and product administration.

Miami, FL There is a growing dispute with physicians who own the CardioGen 82 machines and Bracco Diagnostics, the manufacturer of the CardioGen. According to medical device attorney Brenda Fulmer at Searcy Denney Scarola Barnhart & Shipley, their investigation on behalf of several over-radiated clients has indicated that doctors may have been told by Bracco that it was permissible to use the CardioGen generators beyond the limited time period.

Princeton, NJ The voluntary CardioGen-82 recall by Bracco Diagnostics Inc. last July and the subsequent FDA alert to health care professionals to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans prompted one Tennessee hospital to test more than 100 cardiac patients for radiation exposure. However, in January 2012, the FDA said the CardioGen-82 problems appear to be the result of user error.

Las Vegas, NV Early last year Ken saw his doctor for a stress test. He found out months later that the CardioGen-82 machine failed, which has resulted in Ken having "higher than normal" radiation levels. "It's ironic, I go for a stress test and now I am even more stressed out," says Ken. "If my stress doesn't kill me, what will the radiation do?"

Sarasota, FL The concern for radiation exposure in relation to the recent recall of CardioGen-82 by Italian manufacturer Bracco Diagnostics is obvious. What isn't, are the ancillary concerns—including travel across international borders—at a time when the world remains understandably vigilant with regard to terrorism.

Sarasota, FL On July 15, 2011, the US Food and Drug Administration (FDA) announced the CardioGen-82 recall, a voluntary recall undertaken by the CardioGen-82 manufacturer, Bracco Diagnostics. The recall was announced after the FDA received reports of patients being exposed to more radiation than expected.