AngioDynamics Initiates Voluntary Recall of Its Centros Catheter

AngioDynamics, Inc., a leading provider of innovative medical devices used by interventional radiologists, nephrologists and surgeons for the minimally invasive treatment of cancer and peripheral vascular disease, announced that it has initiated a voluntary recall of all hospital inventory of Centros™, its self-centering central venous catheter for dialysis.

The Company became aware that 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 U.S. Food and Drug Administration review, shipments of Centros are expected to resume during the Company’s fiscal third quarter, which begins Dec. 1, 2008.

AngioDynamics has shipped approximately 1,500 Centros catheters as part of a limited launch since January 2008. The number of instances reported to date amount to fewer than 1% of the products shipped. AngioDynamics is informing all affected customers of the recall action and noted that no adverse patient outcomes have been reported as a result of this issue.

These Customer Notification actions are being taken with the knowledge of the U.S. Food and Drug Administration. Physicians, hospitals and patients with product related questions may call AngioDynamics Customer Service at 1-800-772-6446.

The Company expects the total costs associated with the recall to be minimal.

SOURCE: Businesswire