MEDITATION SHOULDER. Anvisa Registry No. 10341350592. Affected lots: 11B15B6, 11B23B7, 11C09BA and 11C16B9. 의 안전성 경고

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.

Boston Scientific became aware, through customer complaints, that the 0.035 "internal diameter dilator (ID) may have been mislabeled as a 0.038" dilator. According to the company, injuries are not expected to occur as a result of this incorrect labeling, as it would not be possible to advance the dilator through the guidewire. Due to the exchange of labeling, there may be a delay in the procedure during the exchange of devices by the surgeon. #### UPDATE - 02/24/2012 - The company forwards the final report of the field action, declaring the total collection of the affected and forwarded products to the manufacturer. ####