Z-2442-2021Class II

MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super...

Name: Z-2442-2021 MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super...
Creator: Mivi Neuroscience Inc
Published: 2021-07-23
License: https://open.fda.gov/license/

Mivi Neuroscience, Inc. / initiated 2021-07-23 / Terminated / root cause: packaging

FDA source

Mivi Neuroscience Inc began a recall of 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... on 2021-07-23. FDA classified it as Class II and gives the reason as "There is potential for nonsterility of product due to a possible defect in the pouch seal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2442-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-23
Posted: 2021-09-09
Terminated: 2024-05-23
Recalling firm: Mivi Neuroscience, Inc.
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.
Product code: DQY Catheter, Percutaneous
Reason for recall: There is potential for nonsterility of product due to a possible defect in the pouch seal.
Root cause tag: packaging
FDA root cause: Packaging
Action: 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 [email protected]. 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: [email protected] Monday through Friday 8:00am to 4:30pm, Central Time.
Quantity in commerce: 68 units
Distribution: US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2442-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2441-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-15	2021-09-09
Z-2442-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-15	2021-09-09

Product code DQY

K151396Class IIMIVI Mi-AXUS Guide CatheterMivi Neuroscience, Inc. / cleared 2015-12-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)