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U.S. Department of Health and Human Services

Class 2 Device Recall MIVI Super 90 Guide Catheters

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 Class 2 Device Recall MIVI Super 90 Guide Catheterssee related information
Date Initiated by FirmJuly 23, 2021
Create DateSeptember 09, 2021
Recall Status1 Terminated 3 on May 23, 2024
Recall NumberZ-2442-2021
Recall Event ID 88408
510(K)NumberK151396 
Product Classification Catheter, percutaneous - Product Code DQY
ProductMIVI 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.
Code Information 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.
FEI Number 3011410509
Recalling Firm/
Manufacturer		 Mivi Neuroscience Inc
6545 City West Pkwy
Eden Prairie MN 55344-3248
For Additional Information ContactMr. Randy LaBounty
952-944-3834
Manufacturer Reason
for Recall		There is potential for nonsterility of product due to a possible defect in the pouch seal.
FDA Determined
Cause 2		Packaging
ActionThe recalling firm, MIVI Neuroscience, Inc., first notified clinical study sites of the recall by memo dated 7/23/2021 issued via email on 7/23/2021.The memo instructed the investigational study site to quarantine and return all of the affected catheters in their EVAQ Clinical Trial inventory. The site was informed the recalling firm is working to resolve the issue to provide replacement units to continue enrolling in the EVAQ Trial. They were instructed to not enroll any subjects until replacements are received. The recalling firm issued letters to their commercial customers dated 8/2/2021 on 8/2/2021 via email and certified mail. The customers were instructed to do the follow: Immediately examine your inventory and quarantine all products subject to this recall. All quarantined products should be returned to MIVI Neuroscience. 2. Please complete the Medical Device Recall Return Response attached. 3. Return the response form no later than 28 August 2021 to customerservice@mivineuro.com. 4. Return your unused inventory listed on the response form to the address listed below with the Return Authorization: RA66. 5. We will issue a credit for the devices returned. If you have any questions, contact VP Quality, Regulator and Clinical at (952) 944-3834 or email: customerservice@minineuro.com Monday through Friday 8:00am to 4:30pm, Central Time.
Quantity in Commerce68 units
DistributionUS Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQY
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