MIVI Super 90 8F Guide Catheter — Class II medical device recall Z-2442-2021
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-2442-2021 |
|---|---|
| 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 | 68 units |
| Reason classes | packaging |
| Lot numbers | M20120006, M21010009, M21030006, M21030007, MIA-9090S-IDE |
| Model numbers | M20120006, MIA-9090S-IDE, MIA-9095S-IDE |
| Expiration dates | 2021-09-10, 2021-12-10 |
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 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-2442-2021. 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.