Recall Z-2442-2021 ยท DQY Catheter, Percutaneous
Mivi Neuroscience Inc
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.
| Date | Jul 23, 2021 |
| Status | Terminated |
| Reason | There is potential for nonsterility of product due to a possible defect in the pouch seal. |
| Root cause | Packaging |
| Action | 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 8/2/2 |
| Quantity | 68 units |
| Distribution | US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151396 | MIVI Mi-AXUS Guide Catheter Mivi Neuroscience, Inc., Dec 9, 2015 |