Mivi Neuroscience Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Mivi Neuroscience Inc
Lot Codes / Batch Numbers
Cat. #MIA-9095S - Lots M20090013, exp. 9/10/2021, and M20110008, 10/26/2021. Cat. #MIA-9095S-E - Lots M20090012, exp. 9/10/2021, M20110007, exp. 10/26/2021, M21030017, exp. 10/26/2023, M21030018, exp. 9/10/2023, M21040003, exp. 4/24/2024, M21050014, exp. 1/27/2023, M21050015, exp. 1/27/2023, M21060002, exp. 2/7/2023, and M21060003, exp. 3/12/2023. Cat. #MIA-9090S - Lot M20110006, exp. 10/27/2021. Cat. #MIA-9090S-E - Lots M20080005, exp.8/6/2021, M20090011, exp. 9/10/2021, M20110005, exp. 10/27/2021, M21010008, exp. 12/10/2021, M21030014, exp.12/10/2023, M21030015, exp. 12/10/2023, M21050013, exp. 12/10/2023, M21060006, exp. 4/3/2022, M21060007, exp. 10/30/2022, M21060008, exp. 10/30/2022, M21060009, exp. 1/27/2023, M21060010, exp. 1/27/2023, M21060011, exp. 3/12/2023, and M21060012, exp. 12/10/2023. Cat. #MIA9080S - Lot M20110009, exp. 10/27/2021. Cat. #MIA 9080S-E - Lots M21010011, exp. 12/10/2021, M21030005, exp. 10/27/2023, M21030013, exp. 4/30/2023, M21060014, exp. 10/10/2022, M21060015, exp. 10/22/2022, M21060016, exp. 4/30/2023, and M21060017, exp. 12/10/2023.
Products Sold
Cat. #MIA-9095S - Lots M20090013, exp. 9/10/2021; and M20110008, 10/26/2021. Cat. #MIA-9095S-E - Lots M20090012, exp. 9/10/2021; M20110007, exp. 10/26/2021; M21030017, exp. 10/26/2023; M21030018, exp. 9/10/2023; M21040003, exp. 4/24/2024; M21050014, exp. 1/27/2023; M21050015, exp. 1/27/2023; M21060002, exp. 2/7/2023; and M21060003, exp. 3/12/2023. Cat. #MIA-9090S - Lot M20110006, exp. 10/27/2021. Cat. #MIA-9090S-E - Lots M20080005, exp.8/6/2021; M20090011, exp. 9/10/2021; M20110005, exp. 10/27/2021; M21010008, exp. 12/10/2021; M21030014, exp.12/10/2023; M21030015, exp. 12/10/2023; M21050013, exp. 12/10/2023; M21060006, exp. 4/3/2022; M21060007, exp. 10/30/2022; M21060008, exp. 10/30/2022; M21060009, exp. 1/27/2023; M21060010, exp. 1/27/2023; M21060011, exp. 3/12/2023; and M21060012, exp. 12/10/2023. Cat. #MIA9080S - Lot M20110009, exp. 10/27/2021. Cat. #MIA 9080S-E - Lots M21010011, exp. 12/10/2021; M21030005, exp. 10/27/2023; M21030013, exp. 4/30/2023; M21060014, exp. 10/10/2022; M21060015, exp. 10/22/2022; M21060016, exp. 4/30/2023; and M21060017, exp. 12/10/2023.
Mivi Neuroscience Inc is recalling MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (9 due to There is potential for nonsterility of product due to a possible defect in the pouch seal.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Recommended Action
Per FDA guidance
The recalling firm, MIVI Neuroscience, Inc., first notified clinical study sites of the recall by memo dated 7/23/2021 issued via email on 7/23/2021.The memo instructed the investigational study site to quarantine and return all of the affected catheters in their EVAQ Clinical Trial inventory. The site was informed the recalling firm is working to resolve the issue to provide replacement units to continue enrolling in the EVAQ Trial. They were instructed to not enroll any subjects until replacements are received. The recalling firm issued letters to their commercial customers dated 8/2/2021 on 8/2/2021 via email and certified mail. The customers were instructed to do the follow: Immediately examine your inventory and quarantine all products subject to this recall. All quarantined products should be returned to MIVI Neuroscience. 2. Please complete the Medical Device Recall Return Response attached. 3. Return the response form no later than 28 August 2021 to customerservice@mivineuro.com. 4. Return your unused inventory listed on the response form to the address listed below with the Return Authorization: RA66. 5. We will issue a credit for the devices returned. If you have any questions, contact VP Quality, Regulator and Clinical at (952) 944-3834 or email: customerservice@minineuro.com Monday through Friday 8:00am to 4:30pm, Central Time.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, MA, NJ, NY, TN
Page updated: Jan 10, 2026