Alerta De Seguridad para CATETER GUIDER SOFITP (Reg. Anvisa: 10341350444) .. RISK CLASS IV .. Lots Affected: (1) Catheter Guide Guider Softip XF 6F (100cm, 40 ° curve) - Material Code: M003101420 - 10142 - Lot: 9311878 //// (2) Catheter Guide Guider Softip XF 6F (90cm, 40 ° curve) - Material Code: H965100420 - Catalog Number: 10042 - Lot: 9311885.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

According to the manufacturer, withdrawal from the market is being made due to the receipt of 2 complaints about the product in question, which indicated that the label indicated a catheter length different from the actual length of the product. It is believed that the affected lot labels can indicate 100cm, when the actual length is 90cm, or the label can indicate 90cm when the actual length is 100cm. The problem in question, still according to Boston Ltd., affects only two lots of the product in question (see Product Description field). The risk associated with this problem is a possible delay or prolongation of the surgical procedure.