April 17 (Reuters) - The U.S. Food and Drug
Administration on Wednesday classified a recall of Boston
Scientific's ( BSX ) device used to block blood flow during
excessive bleeding or hemorrhaging as "most serious".
An investigation showed that Boston's device, Obsidio
Embolic, when used with a specific technique posed a higher risk
of bowel ischemia during procedures to stop gastrointestinal
(GI) bleeding, the agency said.
Bowel ischemia describes disorders that occur when blood
flow to your intestines decrease, causing severe abdominal pain.
The limited blood flow may lead to prolonged
hospitalization or death, the FDA said.
The health regulator said there were 11 incidents reported,
seven injuries, and two deaths related to this issue.
The recall is a correction, not a product removal, the
FDA said.
On Feb. 21, Boston Scientific ( BSX ) issued an advisory notice
explaining that use of the aliquot technique is not recommended
with Obsidio Embolic when used for procedures treating lower GI
bleeding.
The company said on Wednesday the device's performance
could be altered when used with the aliquot technique. It
continues to recommend that physicians not use the technique
during the procedure.
Boston added that the device remains safe for use as
labeled and continues to be available for treatment of internal
bleeding and hemorrhaging.