Events

Recall Or Safety Alert for ELCA ™ coronary atherectomy catheter, model 110-004, lot number FHH16D05B, FHH16F28A, FHH16G13A, FHH16H24A

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by Spectranetics Corp..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety Alert
  • Date
    2016-11-30
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Removal from the market of certain batches of the ELCA ™ coronary atherectomy catheter, manufactured by Spectranetics Corp., USA, due to a possible defect in the package that may compromise its sterility.

Device

ELCA ™ coronary atherectomy catheter, model 110-004, lot number FHH16D05B, FHH16F28A, FHH16G13A, ...

Manufacturer

Spectranetics Corp.
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    AEMPSVFOI