Medical device manufacturer, Abbott Laboratories Limited has issued a medical device safety alert concerning HT Connect Peripheral Guide Wires. Part numbers from 1012587 to 1012595 are affected.
The above affected products are now being recalled due to a small number of devices exhibiting partial delamination of the PTFE coating. To date, the frequency of worldwide reported incidents of delamination of the coating is 0.08%.
While Abbott has received no reports on long term or irreversible patient effects, potential risks associated with this problem include embolism, thrombus and occlusion in the peripheral vessels.
Abbott has stopped distributing the affected products while evaluating appropriate corrective and preventive actions. The manufacturer will replace the returned unused units with similar products, pending availability.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 November 2013