Microvention AZUR CX 35 Peripheral Coil System Recall: Unsealed Packaging Risk
Microvention recalls AZUR CX 35 Peripheral Coil System Detachable due to potential unsealed pouch packaging. Learn if you have the affected model and what to do.
Lower-risk recall
Peripheral coil system detachable has a potential of unsealed pouch packaging.
Contact the company
What happened, in plain English
Microvention is recalling its AZUR CX 35 Peripheral Coil System Detachable because the packaging might be unsealed. This could lead to contamination or improper use of the medical device. Affected users should check their product details and follow the official recall instructions. Read more at govinfonow.com/recall/57445-microvention-azur-cx-35-peripheral-coil-system-recall-unsealed-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/57445-microvention-azur-cx-35-peripheral-coil-system-recall-unsealed-packaging · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0187-2024
Cite this page
“Microvention AZUR CX 35 Peripheral Coil System Recall: Unsealed Packaging Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57445-microvention-azur-cx-35-peripheral-coil-system-recall-unsealed-packaging. Based on FDA recall #Z-0187-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0187-2024%22&limit=1).
Why it’s dangerous
The peripheral coil system detachable may have unsealed pouch packaging, which could lead to contamination or improper use of the medical device. This poses a low risk of infection or incorrect application during medical procedures.
Who’s affected
Patients using the AZUR CX 35 Peripheral Coil System Detachable for medical procedures are likely affected. Those with the specific model number and lot code from the recall list are at higher risk.
How to tell if you have this one
Check for the model name 'AZUR CX 35 Peripheral Coil System Detachable' and the lot code '0000190693' on the packaging. The product was sold with a specific expiration date of April 30, 2027.
- Brand
Microvention- Category
Medical device
What to do — step by step
Check Product Details
Look for the model name 'AZUR CX 35 Peripheral Coil System Detachable' and lot code '0000190693' on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 8 states.
FDA distribution: “US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Michigan, Nevada, New York, Texas, Virginia, Washington.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0187-2024 (August 24, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0187-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.