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Injuries Reported Among Users of Johnson Johnson Cordis Balloon Catheters

The U.S. Food and Drug Administration (FDA) released frightening news in 2008. A massive recall was initiated for Johnson & Johnson’s Cordis balloon catheters. This recall came after two injuries were reported.

The balloon catheter recall was so serious that the FDA assigned its Class 1 recall to it, meaning there was a realistic probability that these defective catheters could cause serious injury or death. However, at the time of the recall, there were no reported deaths, according to Christopher Allman, the Cordis spokesman.

Allman said the defect involved the Dura Star RX and Fire Star RX balloon catheters. It was estimated that approximately 57,000 balloon catheters in the United States were impacted by the recall.

The defective catheter was believed to have a “potential for slow deflation or no deflation of the agioplasty balloon when inserted into the artery or other blood vessels,” according to the FDA. This major flaw could cause the artery or blood vessels to become blocked, heart rate to change, heart rhythm to change, injury to the heart artery and heart attack. In some cases, surgery could be required.

If you or a family member has used the Johnson & Johnson cathter and have suffered as a result, contact an experienced Tampa injury lawyer at the Law Offices of Lilly, O’Toole & Brown, LLP at (863) 533-5525.

For more information on this topic, read the article, Johnson & Johnson Cordis Balloon Catheter Put Patients at Risk.