Medical device manufacturer, Boston Scientific, has issued a field safety notice concerning 4mm x 15mm small peripheral cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device, and 4mm x 15mm Flextome cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device. The expiration date range from 16 November 2015 to 03 June 2016.
Users may experience significant difficulty or inability to remove protector cap from device which may result in damage to the device. Boston Scientific has received 45 complaints related to this issue from April 2013 to current date, none of which have resulted in patient injury and no additional risk to the patient is expected to occur as a result of this issue.
According to the manufacturer, further distribution or use of affected products should cease immediately. Users should segregate and return affected products to Boston Scientific.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 1 August 2013