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Heart Stents

Heart Stent Recall; 26 Injured, 1 Dead

On October 8, 1998, the FDA issued a press release announcing that Boston Scientific Corporation of Natick, MA, had voluntarily recalled and ceased distribution of its NIR ON Ranger with Sox coronary stent delivery system, due to a serious risk of patient injury. Hospitals have been urged to immediately stop using the device due to the potential risk to patients.

The company had received more than 100 reports of balloon leakage. The company has reported 26 injuries and one death to the FDA.

The company stated to the FDA that the reports of injury were likely attributable to a change in the manufacturing process. FDA states that the change was not reviewed or approved by FDA's product review staff.

This informational piece was prepared by Silverman & Fodera. If you would like more information on this topic, call us at (800) 220-LAW1, or use the "Do I Have A Case?" link on this web site.