MIVI Super 90 Guide Catheters — Class II medical device recall Z-2441-2021
Terminated recall by Mivi Neuroscience Inc, reported 2021-09-15, distributed in FL, MA, NJ, NY, TN. There is potential for nonsterility of product due to a possible defect in the pouch seal.
| Recall number | Z-2441-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mivi Neuroscience Inc, Eden Prairie, MN, United States |
| Recall initiated | 2021-07-23 |
| Classified | 2021-09-09 |
| Reported by FDA | 2021-09-15 |
| Terminated | 2024-05-23 |
| Distributed | FL, MA, NJ, NY, TN |
| Countries outside the US | ES, FR, HU, SI |
| Quantity | 491 units |
| Reason classes | packaging |
| Lot numbers | 9080S-E, M20080005, M20090011, M20090012, M20090013, M20110005, M20110006, M20110007, M20110008, M20110009, M21010008, M21010011, M21030005, M21030013, M21030014, M21030015, M21030017, M21030018, M21040003, M21050013, M21050014, M21050015, M21060002, M21060003, M21060006, M21060007, M21060008, M21060009, M21060010, M21060011, M21060012, M21060014, M21060015, M21060016, M21060017, MIA-9090S, MIA-9090S-E, MIA-9095S-E, MIA9080S |
| Model numbers | 9080S-E, M20080005, M20090012, M20090013, M21010011, MIA-9080S, MIA-9090S, MIA-9090S-E, MIA-9095S, MIA-9095S-E, MIA9080S |
| Expiration dates | 2021-08-06, 2021-09-10, 2021-10-26, 2021-10-27, 2021-12-10, 2022-04-03, 2022-10-10, 2022-10-22, 2022-10-30, 2023-01-27, 2023-02-07, 2023-03-12, 2023-04-30, 2023-09-10, 2023-10-26, 2023-10-27, 2023-12-10, 2024-04-24 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2441-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.