Drug recall
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90…
FDA recall event 88408 · Class II · Mivi Neuroscience Inc
Key facts
| Event ID | 88408 |
|---|---|
| Recall numbers | Z-2441-2021, Z-2442-2021 |
| Recalling firm | Mivi Neuroscience Inc |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is potential for nonsterility of product due to a possible defect in the pouch seal. |
| Initiation date | Jul 23, 2021 |
| Report date | Sep 15, 2021 |
| Termination date | May 23, 2024 |
| City | Eden Prairie |
| State | MN |
| Country | United States |
| FEI number | 3011410509 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: