FDAnews
www.fdanews.com/articles/67587-j-j-withdraws-faulty-stents

J&J WITHDRAWS FAULTY STENTS

January 14, 2005

Johnson & Johnson (J&J) says it withdrew 300 of its Cypher stents and found that six of them had less drug coating than required.

J&J doesn't know if any of the Cypher stents, used to prop open arteries, from the affected lot were implanted in patients, but it has determined that the problem wouldn't affect clinical performance, the company said.

No defects were found in other lots of the heart devices, said Terri Mueller, a spokeswoman for New Brunswick-based J&J. The company said 145 hospital accounts were affected by the withdrawal and replacement stents have been sent to those customers, according to a Bloomberg report.

(http://www.fdanews.com/pub/ddl)