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.

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.

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).

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 Oct-17-11