Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating [Material Number (UPN): H7491490201MJ25Pk and H7491490201MJo; Lot number: 17971870; Expiration Date: 10-May-2017].
The manufacturer has found that, while the batch is labeled as a J-tip model, the guidewires are straight and do not have the pre-formed J-tip. The most severe injury expected to occur is a limited procedure delay caused by the need to replace the guidewire with one that has a J-tip. No patient injuries have been reported.
Product recall is ongoing. The manufacturer instructs affected users to stop distributing or using any remaining products affected by this recall immediately.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 March 2016