Mivi Neuroscience Inc Recall 88408
Description: 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.
Mivi Neuroscience Inc Recall 88408 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2442-2021 |
| Event ID | 88408 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain. |
| Quantity | 68 units |
| Recall Reason | There is potential for nonsterility of product due to a possible defect in the pouch seal. |
| Device Classification | 20210915 |
| Device Code Info | 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. |
| Center Classification Date | 20210909 |
| Recall Initiation Date | 20210723 |
| Recalling Firm | Mivi Neuroscience Inc |
| Initial Notification | Letter |
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