Events

Recall of Prostaflow Prostate Probes

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 Coloplast.

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
    2010-12-06
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/sondes-prostatiques-prostaflow-coloplast-retrait-de-lots
  • 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
    On 30/11/2010, coloplast removed the lots from the market. lots No. 10060259 and No. 10051477 (ref AB7822, lot No. 10061659) (ref AB7824) of the medical device called Prostaflow Prostate Probes, manufactured by Coloplast Following several reports, it has been shown that the valve some of the probes of the concerned batches present a defect which causes the deflation of the balloon The company Coloplast directly warned the recipients of the incriminated batches by means of the enclosed message validated by Afssaps (06/12/2010) ( This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned.

Device

Prostaflow Prostate Probes
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Coloplast

Manufacturer

Coloplast