FDA-Device2020-04-01Class I
Imager II 5F Angiographic Catheters, 5 units per package.
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-1555-2020More Boston Scientific Corporation recalls
- FDA-Device2026-07-22Boston Scientific Rapid Refill Continuous Injection System recalled for syringe disconnection risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for sterile pouch breach risk
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile pouch breach
- FDA-Device2026-07-08Boston Scientific CRE Pro Wireguided catheters recalled for potential sterile packaging breach
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