Interventional technology developer AngioDynamics of Queensbury, NY, has initiated a voluntary recall of all hospital inventory of its self-centering central venous catheter for dialysis.
The Centros catheter cuff, intended to anchor the catheter in subcutaneous tissue, was inadequately attached to the catheter in a few instances, allowing movement of the device in 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 U.S. Food and Drug Administration review, shipments of Centros are expected to resume during the company's fiscal third quarter, which begins December 1.
Since January 2008, AngioDynamics has shipped approximately 1,500 Centros catheters as part of a limited launch. The number of instances reported to date of the catheter's failure amount to fewer than 1% of the products shipped. AngioDynamics is informing all affected customers of the recall and noted that no adverse patient outcomes have been reported as a result of the issue.
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