MIVI Super 90 8F Guide Catheter Recalled Due to Potential Sterility Defect
Mivi Neuroscience is recalling MIVI Super 90 8F Guide Catheters (investigational sterile devices) due to a potential pouch seal defect that could compromise product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile medical device. The potential for loss of sterility on a device used in vascular procedures represents a risk of infection. No illnesses or injuries have been reported, meeting the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Mivi Neuroscience Inc is recalling MIVI Super 90 8F Guide Catheters in two sizes: a 95 cm model (REF MIA-9095S-IDE) and a 90 cm model (REF MIA-9090S-IDE). These are investigational sterile devices used to facilitate insertion and guidance of microcatheters into blood vessels in peripheral, coronary, and neurovascular systems.
The recall was initiated because of a potential defect in the pouch seal that could allow the product to lose sterility. Affected lot numbers include M20120006, M21030007 (95 cm model, expiring 9/10/2021), and M21030006, M21010009 (90 cm model, expiring 12/10/2021).
A total of 68 units were distributed in the United States to Florida, Massachusetts, New Jersey, New York, and Tennessee. Additional units were distributed internationally to France, Hungary, Slovenia, and Spain.
The recalled product
- Product
- 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…
- Manufacturer
- Mivi Neuroscience Inc
- Affected units
- 68
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Mivi Neuroscience Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Mivi Neuroscience Inc
See all →- HighGuide Catheters Recalled for Potential Sterilization Defect
FDA (Devices) · 2021-09-15
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