Mivi Super 90 8F Guide Catheter Recall: Nonsterility Risk
Mivi Neuroscience recalls Super 90 8F Guide Catheters with possible pouch seal defects that could lead to nonsterility. Affected units include specific model numbers and expiration dates.
Lower-risk recall
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Contact the company
What happened, in plain English
Mivi Neuroscience is recalling Super 90 8F Guide Catheters that may have a pouch seal defect causing nonsterility. This could lead to infections or contamination during medical procedures. The recall affects specific model numbers and expiration dates. Read more at govinfonow.com/recall/62165-mivi-super-90-8f-guide-catheter-recall-nonsterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62165-mivi-super-90-8f-guide-catheter-recall-nonsterility-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2442-2021
Cite this page
“Mivi Super 90 8F Guide Catheter Recall: Nonsterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62165-mivi-super-90-8f-guide-catheter-recall-nonsterility-risk. Based on FDA recall #Z-2442-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2442-2021%22&limit=1).
Why it’s dangerous
The catheter pouch seal may be defective, leading to nonsterility. This could cause contamination or infection during medical procedures if the catheter is used without proper sterility.
Who’s affected
Medical professionals using these catheters for investigational procedures are most at risk. The recall applies to specific model numbers and expiration dates listed in the notice.
How to tell if you have this one
Check for model numbers MIA-9095S-IDE or MIA-9090S-IDE with specific expiration dates listed in the recall notice.
- Brand
Mivi Neuroscience- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2441-2021 | 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.; 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. | 491 units |
| Z-2442-2021 | 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.; 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. | 68 units |
What to do — step by step
Check Product Details
Verify the model number and expiration date on the catheter packaging.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
FDA distribution: “US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Massachusetts, New Jersey, New York, Tennessee.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2442-2021 (July 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2442-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.