# FDA recall Z-2441-2021

> **Mivi Neuroscience Inc** · Class II · device recall initiated 2021-07-23.

## Product

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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2441-2021
- **Recalling firm:** Mivi Neuroscience Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-23
- **Report date:** 2021-09-15
- **Termination date:** 2024-05-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eden Prairie, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2441-2021

## Citation

> AI Analytics. FDA recall Z-2441-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-2441-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*