Events

Field Safety Notices about SUMMARY Vapor Ablation for BPH

According to Swedish Medical Products Agency, this field safety notices involved a device in Sweden that was produced by NxThera Inc.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    6.6.4-2015-26841
  • Event Country
    Sweden
  • Event Source
    SMPA
  • Event Source URL
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2016/Flergangsprodukter--Rezum-Vapor-Ablation-for-BPH--NxThera-Inc/#
  • Notes / Alerts
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 Sweden.
  • Extra notes in the data
    MDD15.041
  • Action
    Products have been withdrawn. Upon inspection of the manufacturing history of resectoscope (Urology) found the manufacturer of products had passed the leak test, but had nonetheless been delivered to customers. Four products were delivered in Sweden. The manufacturer has withdrawn and given back the products. Contact the manufacturer for more information.

Device

SUMMARY Vapor Ablation for BPH
  • Model / Serial
  • Product Description
    Reusable Products
  • Manufacturer
    NxThera Inc

Manufacturer

NxThera Inc
  • Source
    SMPA