Recalled CardioGen-82 Linked to Radiation Overdose

CardioGen-82, which uses the radioactive drug rubidium 82 chloride injection for cardiac PET scan or cardiac PET imaging has been recalled by the manufacturer, Bracco imaging. The CardioGen-82 recall occurred after the FDA received two reports of patients who received more radiation than expected.

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CardioGen-82 Cardiac PET Scan Recall

On July 26, 2011 the FDA notified healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans. The CardioGen-82 was voluntarily recalled by Italian manufacturer Bracco Diagnostics.

About 10 days earlier FDA alerted the public, and in particular, the medical imaging community, about the potential for inadvertent, increased radiation exposure in patients who underwent or will be undergoing cardiac PET scans with rubidium (Rb)-82 chloride injection from CardioGen-82. The alert came on the heels of reports from two heart patients who set off security scanners at the U.S. border. Both patients had undergone nuclear testing at a Sarasota FL facility, and their radiation overdose was traced back to the CardioGen-82 at the facility.

About Cardiac PET Scan with CardioGen-82

CardioGen-82 consists of a generator that is used at clinical sites to produce rubidium (Rb)-82 chloride injections, a radioactive chemical tracer used to monitor blood flow through the heart. A CardioGen-82 PET scan is one of a variety of nuclear medicine scans that use radioactive drugs to evaluate the heart. According to Heart Center, Inc., Rubidium Chloride (Rb-82), a low dose radioactive tracer as well as a chemical stress agent is injected intravenously. This test is used to assess coronary blood flow which may identify blocked coronary arteries or heart muscle damage as well as stress and rest ejection fractions (the heart's pumping capability).

FDA and CardioGen-82 Investigation

The FDA determined that the current procedures in place to manufacture CardioGen-82 were insufficient to guarantee reliable performance of the generator used to produce the rubidium 82 injection. Reliable performance is of utmost importance to ensure that patients are not subject to radiation overdose. The FDA said it is working with the Nuclear Regulatory Commission and the CardioGen-82 manufacturer to determine the root cause for the increased radiation exposure detected in the two patients. The agency is also investigating the extent to which other patients may have received inadvertent radiation exposure.

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Last updated on May-11-12

CARDIOGEN-82 ARTICLES AND INTERVIEWS

Patients Rely on Administrators to Ensure CardioGen-82 Is Used Correctly

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 [READ MORE]

CardioGen-82 Returning from Recall, But Who's at Fault?

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 [READ MORE]

Attorney Discusses Possible CardioGen 82 Lawsuits

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 [READ MORE]