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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

EV3 catheter recall: Firm recalls about 350 TrailBlazer support catheters Nov. 6 after receiving reports from physicians of cracking near the radiopaque marker band during the product's limited initial U.S. release. The malfunction could cause injuries such as insufficient oxygen supply to tissues, damage to blood vessels, heart attack or death, FDA said Jan. 5. The firm says the Class I recall was completed in December and all affected units have been returned to the company. A redesigned TrailBlazer support catheter was launched last month and is available worldwide, ev3 notes

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