FDA Device recall Z-2442-2021
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only
- FDA Device
- Class II
- terminated
- Published 2021-09-15
On 2021-09-15 the FDA classified a Class II recall of MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only by Mivi Neuroscience, citing there is potential for nonsterility of product due to a possible defect in the pouch seal.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2442-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-23 |
| Published | 2021-09-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Mivi Neuroscience |
| Distribution | FL, MA, NJ, NY, TN |
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.
Reason
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Identifiers
| code_info | Cat #MIA-9095S-IDE - Lots M20120006, exp. 9/10/2021; and M21030007, exp. 9/10/2021. Cat. #MIA-9090S-IDE - Lot M2103000…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2442-2021%22
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