🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: July 23, 2021 Mivi Neuroscience Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Mivi Neuroscience Inc
Reason for Recall:
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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.

Distribution:

Distributed in: US, FL, MA, NJ, NY, TN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2441-2021

Related Recalls

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.

Mivi Neuroscience

Class I - Dangerous

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

Jul 23, 2021 Surgical Instruments View Details →