Events

Recall of CORODYN TD balloon catheter 7F and 7 F PVC

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by B. Braun.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2005-06-28
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-corodyn-td-catheters-a-ballonnet-b--braun
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Action
    The B. Braun Medical company withdrew from the market on June 24, 2005, the batches (see appendix (24/06/2005) (11 ko)) of the medical device called CORODYN TD balloon catheter 7F and 7 F PVC (references 5041953 and 5041252) following reports of end of cracked caheter, leakage at the 3-way valve and cracked tip .. No report has been reported in France to date. The company has directly notified the recipients of the offending lot with the message attached (24/06/2005) (9 KB) validated by Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

CORODYN TD balloon catheter 7F and 7 F PVC
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    B. Braun

Manufacturer

B. Braun