Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MIVI Super 90 8F Guide Catheter Recalled by Mivi Neuroscience Inc Due to There is potential for nonsterility of product due...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mivi Neuroscience Inc directly.
Affected Products
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.
Quantity: 68 units
Why Was This Recalled?
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Where Was This Sold?
This product was distributed to 5 states: FL, MA, NJ, NY, TN
About Mivi Neuroscience Inc
Mivi Neuroscience Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report