Events

Recall Or Safety Alert for Ultrasound intravascular Volcano systems with accessories: catheters and accessories for imaging systems for intravascular ultrasound and pressure control Volcano s5 and Volcano s5i: device for pulling a single-use catheter Trackback II: 91003

According to Ministry of Health of the Republic of Belarus, this recall or safety alert involved a device in Belarus that was produced by Volcano Corporation, USA.

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
  • Event Number
    ИМ-7.99871
  • Date
    2014-01-10
  • Event Country
    Belarus
  • Event Source
    MHRB
  • Event Source URL
    https://www.rceth.by/ru/Safety/MedSafety
  • Notes / Alerts
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • Extra notes in the data
  • Reason
    Volcano corporation has initiated a voluntary recall of all lots of the device for pulling a single-use catheter trackback ii: code 91003. the trackback ii is intended for use with eagle eye® intravascular imaging catheters. the device provides stable and accurate movement of the catheter, which allows you to evenly collect image data. the recall is initiated by the company as a precautionary measure due to concerns about the integrity of the primary packaging, which may affect the sterility of the product after shipment. volcano corporation has not received any complaints about this and no reports of harm to the patient or his death caused by the use of the product. however, the company asks to immediately stop using the device in trackback ii and return unused devices to the distributor.

Device

Ultrasound intravascular Volcano systems with accessories: catheters and accessories for imaging ...

Manufacturer

Volcano Corporation, USA
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    MHRB