Boston Scientific, as the distributor of NovaGold Guidewire, has issued a medical device safety alert concerning NovaGold Guidewire in coordination with NeoMetrics Incorporated, the manufacturer of the medical device.

The affected products are identified as follow:-

• NovaGold Guidewire .018in. x 260cm:
  • Catalogue no.: 5200; Lot no.: MO26343, MO26345, MO267624, MO27402, MO27660, MO27901;
  • Expiration date: 30-No-2014 to 31-Mar-2017
• NovaGold Guidewire .018in. x 480cm:
  • Catalogue no.: 5201; Lot no.: MO26342, MO26344, MO26731, MO27401, MO27659, MO27820, MO27899
  • Expiration date: 30-No-2014 to 31-Mar-2017

It has come to the attention of Boston Scientific that the tip of the NovaGold Guidewire may uncoil and or detach more frequently than anticipated. The detachment may result in tissue trauma, inflammation, perforation, foreign object in body, retention of fragment, and additional interventions to retrieve the detached device. Boston Scientific advises affected customers to discontinue the use of the affected device immediately.

According to the local supplier, the affected products were not distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 07 April 2014