Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported June 16, 2021
VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Microvention INC. recalled VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter de… - a low-severity action.
VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter de… was recalled by Microvention INC. in June 16, 2021. Reason: Due to inadvertently shipping to U.S. customers with international labeling which has some differences with U…. Check the official notice for the remedy. Verify recall #Z-1828-2021 with the FDA Devices before acting.
The recall
Microvention INC. issued this low-severity FDA Devices recall-Due to inadvertently shipping to U.S. customers with international labeling which has some differences with U….
- Low
- severity level
- Class III
- classification
- June 16, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1828-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1828-2021) was formally reported on June 16, 2021, with the manufacturer initiating the action on April 21, 2021. It is classified under Low severity (Class III), with a current status of Terminated. Microvention INC. is listed as the recalling firm, operating out of Aliso Viejo, CA. Federal records list the affected scope as N/A.
The documented reason for this recall is: Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling. Distribution data in the federal record shows the product reached: U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX.. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
N/A
Related Recalls
6
3 from same agency
Product description
VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
Reason for recall
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1828-2021 |
| Date reported | June 16, 2021 |
| Date initiated | April 21, 2021 |
| Recalling firm | Microvention INC. |
| Firm location | Aliso Viejo, CA |
| Affected scope | N/A |
| Distribution | U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX. |
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-1828-2021) 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? ▼
VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.. Recalled by Microvention INC.. Units affected: N/A.
Why was this product recalled? ▼
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 16, 2021. Severity: Low. Recall number: Z-1828-2021.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide distribution in the states of FL, IA, MI, MN, TN and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1828-2021) 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 June 16, 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.