Catheter mislabelling leads to Boston Scientific recall in Brazil:
This article was originally published in Clinica
Executive Summary
Boston Scientific is recalling two lots of its Guider Softip XF guide catheters in Brazil, as a result of a "quality deviation" involving a product/labelling mismatch, regulatory agency Anvisa reports. According to a July 19 notice, the affected lots of 90cm and 100cm catheters were distributed with labelling describing them as being 100cm and 90cm, respectively. Sao Paulo-based Boston Scientific do Brasil reportedly received two surveillance alerts and has confirmed to Anvisa that only two lots were affected. The risk the transposed descriptions pose is that the surgical procedure might be delayed or protracted, according to the agency.