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Just the Dates
July 1, 2003
2 Min Read
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Originally Published MX July/August 2003
BUSINESS NEWS
Guidant's guilty pleas relate to failure to report more than 2600 implantation malfunctions that are believed to have resulted in 12 deaths, and more than 50 emergency surgeries, in the period from 1999 to 2001. Following is a chronology of the short, troubled market life of the Ancure endograft system.
September 1999: | FDA approves Ancure for U.S. market. |
|---|---|
October 2000: | FDA receives anonymous letter from seven EVT employees, claiming cover-up of delivery problems. |
March 2001: | Guidant voluntarily withdraws Ancure system, citing problems with the delivery procedure. |
September 2001: | FDA permits Ancure return to market, with revised labeling and physician use instructions. |
August 2002: | Guidant acknowledges it is subject of criminal investigation. |
June 2003: | Guidant admits wrongdoing, agrees to $92.4 million fine. |
October 2003: | Ancure system to be withdrawn from the market. |
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