Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its JETSTREAM Atherectomy Catheters.
The manufacturer is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm [Material numbers: 112262-001, 112262-003; Lot numbers: 18775553, 18775552; Expiration Date: 24 December 2017] and one lot of JETSTREAM XC 2.1mm [Material number: 112264-001; Lot number: 18822086; Expiration Date: 24 December 2017] Atherectomy Catheters due to these units being mislabeled. Some 1.85mm JETSTREAM SC catheters may have been labeled as 2.1mm catheters, and some 2.1mm JETSTREAM XC catheters may have been labeled as 1.85mm catheters. The affected units that were distributed between January and September 2016 are labeled as Bayer product.
According to the manufacturer, the most reasonably foreseeable consequence of this situation would be an insignificant prolongation of the procedure to exchange the device for another. There have been no reported patient adverse events as a result of this issue.
The affected users are advised to immediately remove all affected products from their inventory (whether in Central Service, Shipping and Receiving, or any other location) and segregate the affected products in a secure location for return to the manufacturer.
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 18 April 2017