FDA-Device2021-09-15Class II
MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
Mivi Neuroscience Inc
Hazard
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Sold states
US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.
Affected count
491 units
Manufactured in
6545 City West Pkwy, N/A, Eden Prairie, MN, United States
Products
MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2441-2021Don't want to check this manually?
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