MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide
Summary
The FDA issued a Class II for MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational U by Mivi Neuroscience Inc. Reason: There is potential for nonsterility of product due to a possible defect in the pouch seal..
Details
Source
Device Recall
External ID
Z-2442-2021
Action Date
2021-09-15
Status
Terminated
Category
device
Product Description
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.
Lot/Code Info: Cat #MIA-9095S-IDE - Lots M20120006, exp. 9/10/2021; and M21030007, exp. 9/10/2021. Cat. #MIA-9090S-IDE - Lot M21030006, exp. 12/10/2021, and M21010009, exp. 12/10/2021.
Quantity Affected: 68 units
Reason for Recall
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Distribution
US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-23
Company
Eden Prairie, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mivi Neuroscience Inc has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mivi Neuroscience Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mivi Neuroscience Inc have FDA actions?
Mivi Neuroscience Inc has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2442-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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