On December 21, 2010, Arrow International announced a recall of its 5800 Series Intra-Aortic Balloon (IAB) Catheters with Super Arrow-Flex Sheath Introducer. Arrow International is a subsidiary of Teleflex Incorporated, a global provider of medical technology products.
This recall comes on the heels of an increase in “stuck in sheath” reports involving the use of the Super Arrow-Flex Sheath with 5800 Series IAB products. According to reports, when the IAB becomes stuck in sheath, the user is unable to move the IAB catheter forward or backward, which can defeat the purpose of the instrument and cause significant delay in treatment. Additionally, when the IAB is stuck in sheath and the user attempts to dislodge the catheter by manipulating it, this may result in “excessive bleeding, arterial damage, significant vasospasm, prolonged tissue ischemia, tissue/vascular ischemia, injury, infarct, or death.”
The U.S. Food and Drug Administration (FDA) has classified this as a Class I recall. The FDA defines Class I recalls as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” All healthcare facilities are being directed to immediately discontinue the use of the device and return all unused 5800 Series IABs with Super Arrow-Flex Sheath Introducers to Arrow International. This recall affects products shipped between January 1, 2009 and December 17, 2010. If you are a loved one has suffered adverse reactions from the use of this device, you should consult a products liability attorney immediately to protect your legal rights and determine your options with regards to compensation.