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J&J biliary stent recall

This article was originally published in The Gray Sheet

Executive Summary

Cordis initiates Class I recall of recently revised instructions for its Precise RX biliary stent following 16 reports of adverse events and/or stent malfunctions related to off-label use in the peripheral vasculature, resulting in nine patient injuries including coma and seizure, the company reports May 7. "We regret our initial communication did not more strongly reinforce against off-label use," Dennis Donohoe, MD, Cordis VP-regulatory and clinical affairs, says in a release. The revised instructions were part of a Cordis Medical Device Notification sent to endovascular customers March 29 without FDA clearance. A May 4 follow-up notification describes the adverse events...
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