Reported Feb 19, 2020 · Terminated

Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and…

Microvention, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Microvention, Inc. · 35 Enterprise · Aliso Viejo, CA · 92656-2601

Is this the product you have?

  • Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA
  • Distributed ByTerumo Medical Corporation, Somerset, NJ; Made in Costa Rica
Lot codes and dates
  • Catalog/lot numbers
    • 45-681026 - 1903085J5
    • 1903155J5
    • and 1904035J5
    • 45-681434 - 1903015J5
    • 1903155J5
    • and 1904155J5
    • 45-682050 - 1903085K5
    • 1903135J5
    • 1903155J5
    • 1904015J5
    • 1904155J5
    • 1904175J5
    • and 1905105K5
    • and 45-680820 - 1903045J5
    • 1903085K5
    • 1903155J5
    • 1904015J5
    • 1904035J5
    • and 1904155J5
Amount recalled
107 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

The devices may be missing the implant coil.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 20, 2021 · Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.