Recall Z-2442-2021— Mivi Neuroscience Inc
Class II · Terminated
Class II FDA medical device recall by Mivi Neuroscience Inc, initiated 2021-07-23, terminated 2024-05-23. It names one FDA 510(k) clearance: K151396. 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..
- Recalling firm
- Mivi Neuroscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-23
- Terminated
- 2024-05-23
- Firm location
- Eden Prairie, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Data sourced from openFDA. This site is unofficial and independent of the FDA.