MIVI Super 90 Guide Catheters 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 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and M…

Recall number

Z-2441-2021

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 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.