WARREN, NJ (May 10, 2004) – The Cordis Endovascular division of Cordis Corp., a Johnson & Johnson company, is recalling revised instructions for the Precise RX Nitinol Stent Transhepatic Biliary System, contained in its Medical Device Notification dated March 29, 2004, the company announced on Friday.
Biliary stents are flexible tubular devices used to drain the biliary tract and to keep the bile duct open.
Use of the Precise RX Stent System, which is cleared to treat obstruction of the bile duct due to malignancies, is reported to result in serious problems at times when used in the vascular system, the company said. Such use is outside of the approved indications.
Cordis said it is aware of nine patient injuries due to air embolism, includingseizure and coma, as well as seven incidents of device malfunction in connection with the use of the system outside of its approved indication.
The Class I recall is for the revised use instructions that were not cleared by the FDA and were contained in Cordis’ Medical Device Notification mailed to its endovascular customers on March 29, 2004, the company said. On May 4, Cordis said it sent a follow-up notification to customers describing “severe adverse events” and advising them to limit the use of the device to the FDA-cleared uses only.
The stent’s labeling contains a warning that the safety and effectiveness of the device for use in the vascular system have not been established.
Dr. Dennis Donohoe, worldwide vice president of regulatory and clinical affairs for Cordis Corp., said “We regret our initial communication did not more strongly reinforce against off-label use.”
A Class I recall is the most serious type of recall. It is a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences.