Safety Alert for COMMERCIAL NAME: VASCULAR STARCLOSE CLOSURE SYSTEM, REGISTER NUMBER: 80146501353, CLASS: IV - MAXIMUM RISK, LOTS: 43034-6H at 47139-6H

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.

The implication of the quality deviation, that is, the release of the clip that does not occur in the correct place, is noticeable at the time of use of the product. The remedial action, if the problem is verified, is the use of manual compression. There are no long-term consequences on the use of the product. We imported 2 lots, total of 260 units, that fit within this range. The Company explains that there is no record of any contact at Abbott Laboratories Customer Service Center regarding the product. Of these 260 units, 05 were effectively used in Brazil. These units did not present a quality deviation and the patients follow well without any postoperative complications. Of the 260 units imported, 200 units of lot 45052 were not even distributed in the country and are already segregated for return to the manufacturer. Of the 60 units of lot 45053, 48 units are segregated to be returned to the manufacturer, the remaining 12 units were distributed as follows: - 07 units were used in medical demonstration (not used in patients); - 05 units were marketed. The UTVIG - Technovigilance Unit will be accompanying the entire return process.