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IVAD recall designated Class I

This article was originally published in The Silver Sheet

Executive Summary

Thoratec has initiated a worldwide recall of implantable ventricular assist devices (IVADs) due to problems with the product's driveline. Seven reports of damaged drivelines in the IVADs - which resulted in five patient injuries and one death - have been received by the firm, leading it to submit a Class II recall notification to FDA Oct. 19, later upgraded by FDA to Class I. The affected models were manufactured and distributed after October 2004. The current instructions for use say the IVADs can be placed internally, or in the paracorporeal (external) position. When outside the body, the device's driveline can be damaged if it is bent at a sharp angle, potentially reducing or interrupting circulatory support to the patient, the firm says

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