Events

Safety Alert for EXCOR® arterial cannula with graft CGRG-021

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Berlin Heart GmbH.

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
    Safety alert
  • Date
    2012-08-07
  • Event Date Posted
    2012-08-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120807.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: berlin heart excor® arterial cannula with graft cgrg-021 the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a field safety notice concerning excor® arterial cannula with graft cgrg-021 manufactured by berlin heart gmbh. during the period from october 2011 to july 2012, the excor® arterial cannula with graft cgrg-021 (6 mm graft arterial cannula) was subject to a limited market launch with product monitoring. while evaluating the clinical data, berlin heart received an increasing number of cases in which, according to customer feedback, seroma and bleeding in the region of the graft material occurred. an analysis of the cause is in process. there is the risk that for patients who are provided with the excor® arterial cannula with graft cgrg-021 could experience seroma and bleeding, and as a result may require re-operation with a cannula exchange in individual case. on the basis of this information, berlin heart has decided to recall the excor® arterial cannula with graft cgrg-021 from the market. all other arterial cannulae from the product range continue to be available without limitation and can be used for implantations. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 august 2012.

Device

EXCOR® arterial cannula with graft CGRG-021
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Berlin Heart EXCOR® arterial cannula with graft CGRG-021
  • Manufacturer
    Berlin Heart GmbH

Manufacturer

Berlin Heart GmbH