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Johnson Johnson Cordis Balloon Catheter Put Patients At Risk

In 2008, Johnson & Johnson’s Cordis subsidiary announced a global recall of approximately 132,000 balloon catheters. These Johnson & Johnson catheters were used to expand blood vessels, but were pulled off the market after it was discovered that these defective medical devices could lead to injury and death. This recall followed two reported injuries.

Christopher Allman, the Cordis spokesman, said that no deaths were reported at the time regarding the defect with the Dura Star RX and Fire Star RX balloon catheters. The balloon catheter recall was believed to have affected about 57,000 devices in the United States. It is important to note that the recall didn’t impact Cordis’s Cypher drug-coated stent heart device. The stent is not delivered through the balloons.

The initial Cordis cathter recall was made on January 14, 2008. The U.S. Food and Drug Administration (FDA) announced the voluntary recall on its website, assigning it the most serious designation of “Class 1 recall.” A Class 1 recall means that there is a reasonable probability that the use of the product will result in serious injury or death.

According to a statement on the FDA’s website, “the product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels.” This problem may cause the following:

  • Total blockage of the artery or blood vessels
  • Change in the heart rate
  • Change in heart rhythm
  • Injury to the heart artery
  • Heart attack
  • Need for surgery

These recalled catheters were manufactured in Mexico from February to December 2007 and distributed globally from March 26, 2007 to January 8, 2008.

If you or a loved one has been injured from a recalled or defective catheter, you may be entitled to compensation. Contact an experienced Orlando injury lawyer at the Law Offices of Lilly, O’Toole & Brown, LLP at (863) 533-5525.