HHS NEWS

U.S. Department of Health and Human Services


P98-29                          FOOD AND DRUG ADMINISTRATION    
FOR IMMEDIATE RELEASE           Sharon Snider:       301-827-6242
October 8, 1998                 
                                Consumer Inquiries:  800-532-4440

BOSTON SCIENTIFIC ISSUES NATIONWIDE RECALL OF HEART STENT

Boston Scientific Corporation, headquartered in Natick, Mass., announced on October 5 that it has stopped distributing its NIR ON Ranger with Sox coronary stent delivery system and is voluntarily withdrawing the product from the market due to a serious risk of patient injury. The Sox system is one of two delivery systems marketed for the stent. The recall will be handled by the company's Maple Grove, Minn., facility.

The FDA considers the withdrawal to be a total product recall. FDA urges hospitals to immediately stop using this device because of potential risk to patients.

The product, launched in early August, was shipped to more than 200 hospitals and medical centers throughout the United States. Approximately 36,000 systems have been shipped and the company estimates 25,000 have been used.

The device is implanted in patients to help keep open previously blocked heart arteries after the blockage has been cleared. It has been popular with doctors because of its thinness and ease of manipulation, which allow it to be used in small or twisting coronary arteries.

The firm's decision to recall the product was based on their receipt of more than 100 reports of balloon leakage. The company has reported 26 injuries and one death to the FDA. The balloon is a key element in the coronary stent system. After the stent is positioned, the balloon is expanded and as it expands, it pushes the stent up against the plaque, the fatty tissue blocking the artery wall. The balloon is then deflated and withdrawn, leaving the stent permanently in place to prop open the blood vessel.

The company has stated that the reports of injury were likely attributed to a change in the manufacturing process that affected the balloon only. That change was not reviewed or approved by FDA's product review staff.

There are two delivery systems for the NIR ON Ranger: one with Sox and one without. As the firm recalls the NIR ON Ranger with Sox, the NIR ON Ranger coronary stent without Sox will continue to be available. The company has evaluated that system and indicated to FDA that it performs as specified and as labeled.

Hospitals with questions may contact the company at 1-888-724-6334.

FDA is disseminating additional information to physicians through health care professional organizations to alert them to the problem.

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