Interventional technology developer Cordis Endovascular is recalling revised instructions for use of its Precise RX nitinol stent transhepatic biliary system.
Cleared by the Food and Drug Administration to treat obstruction of the bile duct due to malignancies, Precise RX has been reported to result in serious problems in some cases when used in the vascular system, which is outside of the FDA's approved indications for the stent, according to the Warren, NJ-based firm.
Cordis said it's aware of nine patient injuries due to air embolism, including seizure and coma, as well as seven incidents of device malfunction in connection with using the system outside of its approved indication. The company initiated the Class I recall of its March 29 medical device notification, which includes revised instructions that were not cleared by the FDA; the stent's labeling had contained a warning that the safety and effectiveness of the device for use in the vascular system have not been established.
On May 4, Cordis sent a follow-up notification to customers describing these severe adverse events and advising them to limit the use of the device to the FDA-cleared uses only. Cordis said that it regrets its initial communication did not more strongly advise against off-label use.
By AuntMinnie.com staff writers
May 10, 2004
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