The Recall Desk

FDA (Devices) recall action 88408

Mivi Neuroscience Inc recalled 2 products on 2021-09-15

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-09-15
Critical
0
Units
559

Why these products were recalled

There is potential for nonsterility of product due to a possible defect in the pouch seal.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2021-09-15

    Guide Catheters Recalled for Potential Sterilization Defect

    Mivi Neuroscience is recalling 491 MIVI Super 90 Guide Catheters due to potential nonsterility from a pouch seal defect. The catheters are used to guide microcatheters in vascular procedures.

    Product
    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 selecte
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2021-09-15

    MIVI Super 90 8F Guide Catheter Recalled Due to Potential Sterility Defect

    Mivi Neuroscience is recalling MIVI Super 90 8F Guide Catheters (investigational sterile devices) due to a potential pouch seal defect that could compromise product sterility.

    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 blo
    Category
    Distribution
    5 states