Boston Scientific is in trouble after regulators discovered last month that the company shipped a number of faulty devices to hospitals. The FDA issued the strongly-worded warning this week after investigators determined that the company shipped the defective devices from its Quincy, Massachusetts, distribution center instead of quarantining them after quality problems were discovered. The specific devices involved include eight Taxus coronary stents, five Vaxcel ports and an unknown number of Symmetry balloon catheters.
The disclosure comes after a series of complaints about quality control procedures at the company over the past two months. In its warning letter, the FDA said the problems "indicate a complete failure of your quality system, and are significant and serious."
- see this story from the Boston Globe