FDA Recalls Cordis Balloon Catheters with Potentially Fatal Defects

• Medical device used to open blocked blood vessels could fail to properly function.
  

On this Page:

• Heart Patients Risk Serious Injury or Death
• The Injuries
• Who may be injured?
• The Recalled Balloon Catheters
• Contact an injury lawyer at Kershaw Cutter & Ratinoff

Heart Patients Risk Serious Injury or Death

Balloon catheters are used in the medical procedure known as percutaneous transluminal coronary angioplasty or PCTA.  In this surgical procedure, narrowed or blocked blood vessels or arteries of the heart are “opened” using the balloon catheter.  Basically, the surgeon inserts the balloon catheter into the blocked artery, then inflates it to clear the blockage.  The surgeon then deflates the balloon before removing it from the artery.  It is critical for the balloon to deflate completely to allow the free flow of blood to resume.

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The Injuries

The defective Cordis balloon catheters have the potential to continue to block the blood vessels during the procedure by either failing to deflate or deflating too slowly.  When this happens, the patient can be injured in the following ways:

• Heart attack
• Death
• More extensive surgery
• Change in the heart rate or heart rhythm
• Injury to the coronary artery

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Who may be injured?

• Heart patients who used the Cordis “Dura Star RX” or “Fire Star RX PTCA” balloon catheter while undergoing balloon angioplasty in the U.S. between August 29, 2007 and January 8, 2008 (worldwide between March 26, 2007 through January 8, 2008);

• Heart patients who experienced complications during or after a balloon angioplasty procedure using the Cordis Balloon Catheter.

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The Recalled Balloon Catheters

On January 14, 2008, Johnson & Johnson issued a worldwide recall of its “Dura Star RX” and “Fire Star RX PTCA” balloon catheters made by Cordis Corporation, a subsidiary of Johnson & Johnson. 

• Approximately 57,000 of the defective devices were distributed in the United States between August 29, 2007 and January 8, 2008. 
• Worldwide, the devices were sold from March 26, 2007 through January 8, 2008.
• All “Dura Star RX” and “Fire Star RX” Lots 13173912 through 13315455 have been recalled. 
• Also, some 52 additional lots above 13315455 are affected. 
• No lots above 13329055 are affected.

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Contact the injury attorneys of Kershaw, Cutter & Ratinoff

The personal injury lawyers of Kershaw, Cutter & Ratinoff have handled hundreds of cases involving dangerous and defective medical devices.  Recently, KCR has litigated and settled numerous nationwide cases involving such medical devices and products as cardiac defibrillators and pacemakers, drug eluting stents, surgical anti-adhesion gel, Vioxx, and the Phen-fen diet drugs.  We have the specific knowledge and experience to help our injured clients obtain fair compensation in these complex cases.

If you, a friend or family member experienced complications during or after a balloon angioplasty procedure in which a recalled defective Cordis “Dura Star RX” or “Fire Star RX PTCA”was used, you may be entitled to compensation for medical treatment, hospitalization, lost wages, pain and suffering, and other damages.

Please click here for a free case evaluation.

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