The cuff on the device, which is used to anchor the catheter during dialysis procedures, was inadequately attached in some instances. That allowed the entire catheter to move, causing leakage around the site, or left the cuff inside the insertion site when the catheter was removed in some cases.
The defect is likely due to a manufacturing defect, the company said.
Shipments of Centros are expected to continue during the company’s fiscal third quarter, pending FDA review, said the company in a statement.
Since January, the company has shipped about 1,500 catheters as part of a limited launch. To date, the number of instances reported is less than 1 percent of those shipped products.
Hospitals, patients and physicians with product related questions can contact AngioDynamics customer Service directly at 1-800-772-6446.