Not long ago, stents were a hot business. Lately, though, the little devices are causing Johnson & Johnson big trouble. Studies released earlier this year questioned their safety due to blood clots, causing sales to decline sharply. In fact, stent problems were cited as a key reason for J&J’s recent decision to eliminate more than 4,300 jobs.

Now, the House Energy & Commerce Committee has sent letters to J&J and the FDA wanting to know why sales of its Cypher stent were allowed to continue even after agency inspections in 2004 turned up numerous manufacturing problems at J&J’s Cordis unit. In their letters, committee chair John Dingell and Bart Stupak, who chairs the subcommittee on oversight and investigations, ask for e-mails, meeting notes, records of phone calls and agency reports.

An FDA warning letter sent to J&J in 2004 noted there were “numerous systemic violations resulting in the adulteration of Cypher stents” found at various Cordis facilities. “Despite these numerous violations, however, Cordis was allowed to continue marketing Cypher stents.” In other words, they want to know why the FDA gave J&J a pass.

These are the letters to J&J and the FDA