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Boston Scientific Corporation recalls Imager II 5F Angiographic Catheters, 5 units per package.
Recalled April 1, 2020 · FDA recall Z-1555-2020 · Boston Scientific
Hazard
Potential for tip detachment of Imager II 5F Angiographic Catheters · FDA Class I
Units
1068827 Single Units
Sold at
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.
Description
Potential for tip detachment of Imager II 5F Angiographic Catheters
Product
Imager II 5F Angiographic Catheters, 5 units per package.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →