Boston Scientific Recalls Catheters; FDA Designates as Class I

April 7, 2020, 1:42 PM UTC

Boston Scientific Corporation recalls about 6,100 Imager II 5F angiographic catheters because the catheter tip can become detached during a patient procedure or preparation.

  • Recall identified by FDA as Class I, the most serious type
  • Nine reported injuries
  • Distribution dates July 16, 2018, to Nov. 26, 2019
  • Company wrote to customers on Feb. 11

To view the source of this information click here

To contact the reporter on this story:
Erin McClam in New York at emcclam@bloomberg.net

To contact the editor responsible for this story:
Chakradhar Adusumilli at cadusumilli@bloomberg.net

© 2020 Bloomberg L.P. All rights reserved. Used with permission.

Learn more about Bloomberg Law or Log In to keep reading:

See Breaking News in Context

Bloomberg Law provides trusted coverage of current events enhanced with legal analysis.

Already a subscriber?

Log in to keep reading or access research tools and resources.