According to the company, the catheter cuff, a component intended to anchor the catheter in subquetaneous tissue, was inadequately attached to the catheter in a few instances, allowing movement of the catheter within the insertion site, leakage around the site, or the retention of the cuff in the tissue when the catheter is removed.
AngioDynamics has identified the cause of the cuff problem and believes it is related to an outside manufacturer’s production process. Pending the FDA review, shipments of Centros are expected to resume during the company’s fiscal third quarter, which begins December 1, 2008. The company expects the total costs associated with the recall to be minimal.