FDA-Device2015-04-08Class II
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Boston Scientific Corporation
Hazard
Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in some of the reported cases, this was performed to retrieve the device fragments.
Sold states
Worldwide Distribution - US Distribution to the states of : CA, WI, FL and OH., and to the countries of: Belgium, Czech Republic, Finland, France, Germany, Great Britain, Italy, Spain, Switzerland, Austria, Hungary, Netherlands and Portugal.
Affected count
289
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1355-2015Don't want to check this manually?
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