Events

Recall of VITAL-PORT MRI PETITE VASCULAR ACCESS PORT (SINGLE CHAMBER) - POLYSULFONE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOK (CANADA) INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    23378
  • Event Risk Class
    II
  • Event Initiated Date
    2017-11-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. 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 Canada.
  • Extra notes in the data
  • Reason
    The non-coring needle included with the sets has the potential to dislodge silicone from the septum of the port component. hypothetically this could lead to embolization of a fragment or leakage of medication/injectable fluids into surrounding tissues. neither of these potential consequences has been reported.

Device

VITAL-PORT MRI PETITE VASCULAR ACCESS PORT (SINGLE CHAMBER) - POLYSULFONE
  • Model / Serial
    Model Catalog: IP-S6118 (Lot serial: >10 contact mfr); Model Catalog: IP-S6110 (Lot serial: >10 contact mfr); Model Catalog: IP-S6113 (Lot serial: >10 contact mfr); Model Catalog: IP-S6118-MPIS-NT (Lot serial: >10 contact mfr); Model Catalog: IP-S5118 (Lot serial: >10 contact mfr); Model Catalog: IP-S7029 (Lot serial: >10 contact mfr); Model Catalog: IP-S7129 (Lot serial: >10 contact mfr); Model Catalog: IP-7112 (Lot serial: >10 contact mfr); Model Catalog: IP-9112 (Lot serial: >10 contact mfr); Model Catalog: IP-S6112 (Lot serial: >10 contact mfr); Model Catalog: IP-S7112 (Lot serial: >10 contact mfr); Model Catalog: IP-S9012 (Lot serial: >10 contact mfr); Model Catalog: IP-S9112 (Lot serial: >10 contact mfr); Model Catalog: IP-7110 (Lot serial: >10 contact mfr); Model Catalog: IP-S7010 (Lot serial: >10 contact mfr); Model Catalog: IP-S7110 (Lot serial: >10 contact mfr); Model Catalog: IP-S9010 (Lot serial: >10 contact mfr); Model Catalog: IP-S9110 (Lot serial: >10 contact mfr); Model Catalog: IP-S6010 (Lot
  • Product Description
    VITAL-PORT MRI PETITE VASCULAR ACCESS;VITAL-PORT VASCULAR ACCESS PORT;VITAL-PORT PETITE VASCULAR ACCESS PORT;VITAL-PORT PETITE DUAL LUMEN VASCULAR ACCESS;VITAL-PORT MRI VASCULAR ACCESS SYSTEM PORT;VITAL-PORT MINI VASCULAR ACCESS
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.