FDA Declines Immediate Action on Boston Scientific's Coronary Stents

Strategic Insights -

Boston Scientific Corp. held a meeting with the FDA to discuss the safety-related recall of its coronary stents, and the agency has decided not to take any immediate action. The company has been supplying additional information to the FDA and a second meeting is planned for next week. The FDA continues to review additional information and plans to inspect the company's Galway, Ireland, plant. The recall has been deemed successful in protecting patients, but the agency is still reviewing the company's quality-assurance process.

Key Takeaways:

  • The FDA has declined to take immediate action against Boston Scientific Corp. regarding its coronary stents, following a meeting between the two parties.
  • The company has agreed to supply additional information to the FDA as part of its ongoing review of the stent manufacturing process.
  • The FDA has praised the success of the company's recall efforts, stating that it appears to have been successful in protecting patients.
  • A second meeting between the FDA and Boston Scientific is scheduled to take place next week.
  • The FDA plans to inspect the company's Galway, Ireland, plant as part of its ongoing review.
  • Boston Scientific has issued three recalls, including the latest one on Thursday, involving an additional 3,000 Taxus stents, bringing the total to 99,200.
  • The company has assured doctors that the remaining stents are safe since the last recall on July 16.
  • The FDA meeting was prompted by concerns over the company's quality-assurance process and the need to determine whether the stent manufacturing process is "under control".

Statistics:

  • 99,200: The total number of Taxus stents recalled by Boston Scientific, including the latest recall of 3,000 stents.
  • 3,000: The number of Taxus stents included in the latest recall, announced on Thursday.
  • July 16: The date of the last recall, after which Boston Scientific assured doctors that the remaining stents were safe.
  • 1: The number of meetings between the FDA and Boston Scientific, with a second meeting planned for next week.

Sources:

  • UPI: Natick, Mass., Aug. 6 (UPI)
  • Wall Street Journal: Boston Scientific's stent quality-assurance is "adequate," and that its recall so far appears "successful" in protecting patients.