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.
This recall has been terminated (originally issued July 23, 2021).
- Company
- Mivi Neuroscience Inc
- Recall Initiated
- July 23, 2021
- Terminated
- May 23, 2024
- Recall Number
- Z-2442-2021
- Quantity
- 68 units
- Firm Location
- Eden Prairie, MN
- Official Source
- View on FDA website ↗
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.
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.
Root Cause
Packaging
Action Taken
The 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.