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Guidant voluntary recall of Voyager catheter:

This article was originally published in Clinica

Executive Summary

Guidant has recalled from the market, due to concerns of potential leakage, 1.5mm to 3.5mm versions of its Voyager coronary dilation catheters. The devices are used to unclog arteries. The Indianapolis firm said the withdrawal was voluntary and that it had already contacted the US FDA and other affected international regulatory agencies. The company is currently pursing "root cause analysis and corrective actions" with regard to the catheters, which were launched in the US during the third quarter of 2004.





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