AngioDynamics recalls Centros dialysis catheter

QUEENSBURY, N.Y.—Medical device company AngioDynamics Inc. said July 10 that it has initiated a voluntary recall of all hospital inventory of its Centros central venous catheter for dialysis.

The catheter cuff, which anchors the catheter in subcutaneous tissue, was inadequately attached to the catheter in a few instances, according to AngioDynamics. This caused the catheter to move within the insertion site, leakage around the site, or the retention of the cuff in the tissue when the catheter is removed.

AngioDynamics said it 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.

AngioDynamics said it has shipped approximately 1,500 Centros catheters as part of a limited launch since January. The number of instances reported to date amount to less than 1 percent of the products shipped.

In addition, 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. Physicians, hospitals and patients with product related questions may call AngioDynamics customer service at (800) 772-6446.