Mivi Neuroscience Inc: Medical Device Recall in 2021 - (Recall #: Z-2442-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 23, 2021

Date Posted: September 15, 2021

Recall Number: Z-2442-2021

Event ID: 88408

Reason for Recall:

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

Status: Terminated

Product Quantity: 68 units

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated