Home / Recalls / Mivi Neuroscience Inc / Z-2442-2021

Z-2442-2021 Class II Terminated

Recalled by Mivi Neuroscience Inc — Eden Prairie, MN

Recall Details

Product Type: Devices
Report Date: September 15, 2021
Initiation Date: July 23, 2021
Termination Date: May 23, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 68 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

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.