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Guidant UK recall

This article was originally published in The Gray Sheet

Executive Summary

Guidant withdraws all lots of Voyager RX coronary dilatation catheters with 1.5 mm to 3.5 mm inflated balloon diameters in the UK due to risk of air embolism, according to a Feb. 9 Medical Device Alert released by the Medicines & Healthcare products Regulatory Agency. Guidant's Jan. 31 recall letter reports an incidence rate of less than .02%; the firm will reintroduce the catheters "once appropriate corrective actions have been implemented"...



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