Ross
Well-known member
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA and Boston Scientific notified healthcare professionals of a Class 1
recall of the Boston Scientific Express2TM (bare metal) coronary stent
system. Characteristics in the design of this stent system resulted in
failure of the balloon to deflate and impeded removal of the balloon after
stent placement. Impeded balloon deflation can result in significant patient
complications, including emergency coronary artery bypass graft surgery and
death. Hospitals should immediately discontinue use of any affected units.
Read the MedWatch 2004 safety summary, including links to the FDA/CDRH
recall notice at:
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#EXPRESS2
FDA and Boston Scientific notified healthcare professionals of a Class 1
recall of the Boston Scientific Express2TM (bare metal) coronary stent
system. Characteristics in the design of this stent system resulted in
failure of the balloon to deflate and impeded removal of the balloon after
stent placement. Impeded balloon deflation can result in significant patient
complications, including emergency coronary artery bypass graft surgery and
death. Hospitals should immediately discontinue use of any affected units.
Read the MedWatch 2004 safety summary, including links to the FDA/CDRH
recall notice at:
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#EXPRESS2
