Important Safety Alerts

Medical device manufacturer, Creganna-Tactx Medical, Inc. (Creganna-Tactx) and the distributor, Cordis Corporation, Inc. (Cordis) have issued a medical device safety alert concerning the EMPIRA NC RX PTCA Dilatation Catheter ("75RxxyyyN") and EMPIRA RX PTCA Dilatation Catheter ("85RxxyyyS") [All catalog numbers and all unexpired lots].

Through the investigation of a small number of complaints, Cordis and Creganna-Tactx have observed that the balloon of the affected product, which is covered with a hydrophilic coating, may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. Use of a weakened catheter may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.

The existing labeling in the Instructions For Use states, as part of the "Preparation and Inspection Procedure":
"Gently remove the shipping stylet along with the balloon cover from the catheter" and "Store in a cool, dry, dark place".

In addition to the existing labeling, users are advised about the IFU updates and they should follow the following instructions:

• If unusual resistance is felt during the removal of the shipping stylet and/or balloon cover, do not use this product and replace it with another product."
• Excessive force may damage the balloon region of the catheter. It is known that balloons with hydrophilic coating are susceptible to expansion of the coating at extremely elevated humidity. Therefore, it is important to follow the current labeling, to store the product in a cool, dark and dry place.

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

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

Posted on 25 Jun 2014