MIVI Super 90 8F Guide Catheter recalled over sterility concerns

Recall date

July 23, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Mivi Neuroscience Inc recalls MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide…

Recall number

Z-2442-2021

FDA classification

Class II

Brand / firm

Mivi Neuroscience Inc

Sold / distributed

US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.