French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 recall data from the U.S. and France.
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The company BALT withdraws from the market, as a precaution, the latex balloons XRAY reference BAL1XRAY, BAL2XRAY and BAL3XRAY (all batches) following the premature aging of the latex risk of tearing during successive inflation of the balloon and release the ball of tungsten . These balloons are intended for the embolization of arteriovenous malformations and aneurysms in the neurological and peripheral territories.