Boston Scientific has issued a medical device safety alert concerning its Hurricane RX Biliary Balloon Dilatation Catheter.

The manufacturer is initiating a removal of specific lots/ batches of the affected product in response to an increase in complaints reported for pinholes in the balloon.

According to the manufacturer, the most common potential consequence as well as the most serious potential consequence that is reasonably foreseeable to occur is a prolonged procedure while the device is exchanged. To date, there have been no serious patient injuries reported.

The following actions are recommended to affected users:

• Cease further distribution or use of any remaining product affected by this removal immediately.
• Verify whether any product within user’s inventory is affected.
• If users have identify any product from the affected lots/batches within their inventory, please segregate the product immediately and return it to the manufacturer.

According to the local supplier the affected products are distributed in Hong Kong.

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

Posted on 21 Oct 2021