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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
Recalled September 15, 2021 · FDA recall Z-2442-2021 · Mivi Neuroscience
Hazard
There is potential for nonsterility of product due to a possible defect in the pouch seal. · FDA Class II
Units
68 units
Sold at
US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.
Description
There is potential for nonsterility of product due to a possible defect in the pouch seal.
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.
Manufacturer(s)
Mivi Neuroscience Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →