Mivi Neuroscience Inc FDA Recalls

2 recalls on file across devices, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Class IIJul 23, 2021There is potential for nonsterility of product due to a poss	There is potential for nonsterility of product due to a possible defect in the pouch seal.	Class IIDevices	Jul 23, 2021
MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIClass IIJul 23, 2021There is potential for nonsterility of product due to a poss	There is potential for nonsterility of product due to a possible defect in the pouch seal.	Class IIDevices	Jul 23, 2021