Reported Sep 15, 2021 · Terminated
MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and…
Mivi Neuroscience Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mivi Neuroscience Inc · 6545 City West Pkwy · Eden Prairie, MN · 55344-3248
Is this the product you have?
- 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.
- Lot codes and dates
29 of 29 products
Products covered by this recall Model / number Product as published MIA-9095SLots M20090013, exp. 9/10/2021 MIA-9095S-Eand M20110008, 10/26/2021. - 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 MIA-9090S-Eand M21060003, exp. 3/12/2023. Cat. #MIA-9090S - Lot M20110006, exp. 10/27/2021. - 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 - Amount recalled
- 491 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
There is potential for nonsterility of product due to a possible defect in the pouch seal.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Mivi Neuroscience Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.