This is an update to a previous recall on a ViperSheath Sheath Introducer. It’s now reclassified as a Class 1 recall, which is as serious as it gets.
A ViperSheath Sheath Introducer is a “long-coiled, reinforced, kink-resistant catheter-like tube (sheath) that helps a physician insert a catheter into a blood vessel.” The problem is that every once in awhile this ViperSheath Sheath Introducer might just fracture once it is in place. And that would be all kinds of bad. Because then “patients may need unplanned surgery to remove the fragments or to control bleeding. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation.”
So if you have Lot ranges S28117 through S29174 and catalog numbers VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, and/or VPR-ISH 7 X 45 you need to chunk ’em ASAP.
