Events

Field Safety Notices about SENSATION PLUS® 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Getinge.

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 Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    During internal pressure (leak) testing of the sensation plus 8fr. 50cc, iabc, failures related to the tip seal leak were identified within the lot number listed above. this issue at the catheter tip seal could potentially cause a leak in the balloon and may lead to an interruption of therapy resulting in the need to replace the defective iabc with a new catheter. such occurrences could cause momentary hemodynamic instability in the patient, or potential complications related to vessel bleeding related to replacement of the iab catheter. to date, there have been no reports of serious injury. .

Device

SENSATION PLUS® 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit
  • Model / Serial
    3000043375
  • Manufacturer
    Getinge

Manufacturer

Getinge
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    AMPMDRS