Noticias

Noticias

  • Título: Cook Medical issues global voluntary recall of catheters with Beacon Tip technology
  • Fecha: 02-05-2016

  • Cook Medical has initiated a global, voluntary recall of all catheters with Beacon® Tip technology. This recall includes all lots of catheters with the Beacon Tip technology. The catheters were recalled on April 15, 2016 due to complaints of tip splitting and/or fracture. The U.S. Food and Drug Administration (FDA) has not yet classified the recall. A complete list of products affected by this recall can be found below.

    Catheters with Beacon Tip technology have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Most of the fractures and/or separations were discovered prior to patient contact. The FDA and other regulatory agencies around the world have been notified of this action.

    In 2015, Cook recalled specific lot numbers of Beacon Tip catheters and then expanded that recall to all 4 French lots. Due to an increase in complaints about tip splitting and/or fracture, in April 2016 Cook has now recalled all lots and sizes to assure patient safety around the world.

    “We’ve been investigating a variety of factors including environmental influences and it’s been difficult for us to reproduce the exact failures that our customers have experienced,” said Pete Yonkman, president of Cook Medical and Cook Group. “If we cannot tell our customers how to keep our products safe, then we aren’t comfortable leaving them on the market. It’s a risk we’re not willing to take. Patient safety comes first – period.”



  • Fuente: endovascular.es