Mivi Neuroscience Inc recalls MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, RE

Hazard / Issue

There is potential for nonsterility of product due to a possible defect in the pouch seal.

Issued by

FDA

Affected States: FL, MA, NJ, NY, TN

Lot/Code Info: Cat. #MIA-9095S - Lots M20090013, exp. 9/10/2021; and M20110008, 10/26/2021. Cat. #MIA-9095S-E - Lots M20090012, exp. 9/10/2021; M20110007, exp. 10/26/2021; M21030017, exp. 10/26/2023; M21030018, exp. 9/10/2023; M21040003, exp. 4/24/2024; M21050014, exp. 1/27/2023; M21050015, exp. 1/27/2023; M21060002, exp. 2/7/2023; and M21060003, exp. 3/12/2023. Cat. #MIA-9090S - Lot M20110006, exp. 10/27/2021. Cat. #MIA-9090S-E - Lots M20080005, exp.8/6/2021; M20090011, exp. 9/10/2021; M20110005, exp. 10/27/2021; M21010008, exp. 12/10/2021; M21030014, exp.12/10/2023; M21030015, exp. 12/10/2023; M21050013, exp. 12/10/2023; M21060006, exp. 4/3/2022; M21060007, exp. 10/30/2022; M21060008, exp. 10/30/2022; M21060009, exp. 1/27/2023; M21060010, exp. 1/27/2023; M21060011, exp. 3/12/2023; and M21060012, exp. 12/10/2023. Cat. #MIA9080S - Lot M20110009, exp. 10/27/2021. Cat. #MIA 9080S-E - Lots M21010011, exp. 12/10/2021; M21030005, exp. 10/27/2023; M21030013, exp. 4/30/2023; M21060014, exp. 10/10/2022; M21060015, exp. 10/22/2022; M21060016, exp. 4/30/2023; and M21060017, exp. 12/10/2023.