DLP MEDTRONIC AND FEMORAL DLP MEDTRONIC FEMALE DLP MEDTRONIC AND INSERTION KIT. Anvisa registry n ° 10339190179. Models at risk: 57414, 57417, 57421, 96017 and 96021. Affected lots: see Appendix 1 of the Company Alert Message, available at: http://portal.anvisa.gov.br/wps/ wcm / connect / 6e0ea68048e3a8769f349fc758bf9f01 / Letter + to + Customer + - + FA653.pdf? MOD = AJPERES 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.

Medtronic is initiating a voluntary Recall regarding selected models and batches of DLP® Femoral Cannulas and DLP® Femoral Cannulae and Insertion Kits (containing the affected femoral arterial cannula) due to recent reports in which the user presented difficulty or not was able to connect the cannula to the perfusion circuit tube. See Appendix 1 of the alert message for the affected model and batch numbers. The cannula has a drawing with an elevation in the connector region of the connector which assists in both the sliding of the tube over the burrs and ensures that the tube is once placed in place. Research has confirmed that for specific batches of DLP Femoral Artery, the orientation of the connector burrs is to recede. As a consequence there may be delayed or prolonged procedure, trauma to the patient's vasculature or loss of blood (consequences hitherto not recorded in any report involving the product).