Corporate Compliance

Johnson & Johnson recalls potentially defective stents

Compliance Monitor, January 19, 2005

Admitting it is taking a "conservative" approach, Johnson & Johnson last week voluntarily recalled 300 Cypher heart stents after an audit revealed six of the stents were not up to manufacturing specifications, The New York Times reported January 14.

According to the Times, the stents were shipped from a manufacturing plant in Puerto Rico to 145 hospitals in December. Johnson & Johnson had not confirmed whether any of the stents--drug-coated cylinders used to prop open blood vessels that have been cleared of blockages--had been inserted into any patients.

Despite this uncertainty, the company remained confident that there would be no negative health consequences if a patient received one of the stents. According to the report, the detected defect was that the polymer coating on the six stents in question did not meet specifications. However, every stent had the appropriate amount of sirolimus, which is "a drug that seeps into vessel walls to combat their tendency to form new blockages," the Times reported.

The Times also reported that this is not the first problem for the Puerto Rico plant that manufactured the stents. The facility was cited in 2004 by the Food and Drug Administration for violating manufacturing standards.