medical Class II Updated 2021-09-15

Mivi Neuroscience Inc recalls MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, F

Recalled Product

MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

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-IDE - Lots M20120006, exp. 9/10/2021; and M21030007, exp. 9/10/2021. Cat. #MIA-9090S-IDE - Lot M21030006, exp. 12/10/2021, and M21010009, exp. 12/10/2021.

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