FDA-Device2020-04-01Class I
Imager II 5F Angiographic Catheters, 5 units per package.
Boston Scientific Corporation
Hazard
Potential for tip detachment of Imager II 5F Angiographic Catheters
Sold states
Worldwide distribution. US nationwide, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Cyprus, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, Poland, Russia, Sweden, Slovakia, Turkey, Taiwan, and South Africa.
Affected count
1068827 Single Units
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
Imager II 5F Angiographic Catheters, 5 units per package.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1555-2020Don't want to check this manually?
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