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DEVICE Information

NAME OF COMPANY / MANUFACTURER:
Cordis Corporation, a subsidiary of Johnson & Johnson

NAME OF DEVICES:
Cordis balloon catheters:

• Dura Star RX
• Fire Star RX

RECALL INFO:

The Cordis balloon catheters recall affects devices distributed worldwide from March 26, 2007 through January 8, 2008. The recall includes:

• Dura Star RX and Fire Star RX devices, lots 13173912 through 13315455  
• Also, some 52 additional lots above 13315455 are affected

DEVICE USE:
Balloon catheters are used in a medical procedure to open narrowed or blocked blood vessels or arteries of the heart.

FDA RECALL STATEMENT:
Class 1 Recall: Cordis Corporation Dura Star™ RX and Fire Star™ RX PTCA Balloon Catheters
FDA Web site — January 14, 2008

Balloon Catheters Recall News

Johnson & Johnson's Cordis Unit Issues Recall of Balloon Catheters
The Wall Street Journal — January 25, 2008

J&J Recalls 130,000 Balloon Catheters
AOL Money — January 25, 2008

Johnson & Johnson recalls Star, Dura Star balloon catheters-FDA
Reuters — January 25, 2008

 

 

 

Cordis Balloon Catheters Recall

On January 14, 2008, the FDA issued a Class I Recall of Cordis balloon catheters, a medical device used to open blocked blood vessels. The product has a potential for slow deflation or no deflation when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure, or death.

Topics on this page:

• Heart Patients Risk Serious Injury or Death
• The Injuries
• Who may be injured?
• The Recalled Balloon Catheters
• Experienced Medical Devices Attorneys with Proven Results

 

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 United States 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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Experience Medical Device Attorneys with Proven Results

KCR attorneys have handled hundreds of cases involving dangerous and defective medical devices. We have the specific knowledge and experience to help our injured clients obtain fair compensation in these complex cases. Some of the cases we’ve resolved include:

• $240 Million Guidant Defibrillator Settlement — KCR clients who were injured by malfunctioning Guidant cardiac defibrillators will claim shares of the $240 million fund as part of a 2008 nationwide settlement.
  
  
• In a confidential settlement, our attorneys successfully resolved a case against Johnson & Johnson on behalf of over 200 individuals who alleged that they contracted post operative infections from sutures that had not been properly sterilized.
  
  
• In another case, we successfully resolved a case against a Johnson & Johnson subsidiary, Ethicon, Inc. on behalf of approximately 56 women who allege that they were injured by a defective medical device known as Intergel.

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 fill out and submit the contact form on this page for a free case evaluation or call us toll-free at (888) 285-3333.

 

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