AngioDynamics, a provider of medical devices for interventional radiologists, nephrologists and surgeons, has initiated a voluntary recall of all hospital inventory of Centros, its self-centering central venous catheter for dialysis.
The Queensbury, N.Y.-based company became aware that the catheter cuff, a component intended to anchor the catheter in subcutaneous 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 said it identified the cause of the cuff problem and “believes it is related to an outside manufacturer’s production process.”
Pending an FDA review, the company said that shipments of Centros are expected to resume during its fiscal third quarter, which begins Dec. 1.
AngioDynamics has shipped approximately 1,500 Centros catheters since January.