Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 15, 2021
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.
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Mivi Neuroscience Inc recalled MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; … - a moderate-severity action.
MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; … was recalled by Mivi Neuroscience Inc in September 15, 2021. Reason: There is potential for nonsterility of product due to a possible defect in the pouch seal.. Check the official notice for the remedy. Verify recall #Z-2442-2021 with the FDA Devices before acting.
The recall
Mivi Neuroscience Inc issued this moderate-severity FDA Devices recall-There is potential for nonsterility of product due to a possible defect in the pouch seal..
- Moderate
- severity level
- 68 units
- affected scope
- Class II
- classification
- September 15, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2442-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2442-2021) was formally reported on September 15, 2021, with the manufacturer initiating the action on July 23, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Mivi Neuroscience Inc is listed as the recalling firm, operating out of Eden Prairie, MN. Federal records list the affected scope as 68 units.
The documented reason for this recall is: There is potential for nonsterility of product due to a possible defect in the pouch seal. Distribution data in the federal record shows the product reached: US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
68 units
Related Recalls
6
3 from same agency
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.
Reason for recall
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2442-2021 |
| Date reported | September 15, 2021 |
| Date initiated | July 23, 2021 |
| Recalling firm | Mivi Neuroscience Inc |
| Firm location | Eden Prairie, MN |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2442-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mivi Neuroscience Inc. Units affected: 68 units.
Why was this product recalled? ▼
There is potential for nonsterility of product due to a possible defect in the pouch seal.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 15, 2021. Severity: Moderate. Recall number: Z-2442-2021.
Where was the recalled product distributed? ▼
Distribution: US Distribution to states of: FL, MA, NJ, NY, and TN; and OUS (Foreign) distribution to countries of: France, Hungary, Slovenia, and Spain..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2442-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 15, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.