Reported Feb 19, 2020 · Terminated

Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639,…

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 CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45-780724, 45-780828, 45-780928, MV-AX80202CL, MV-AX80204CL, MV-AX80304CL, MV-AX80308CL, MV-AX80413CL, MV-AX80516CL, MV-AX80620CL, MV-AX80724CL, MV-AX80828CL, MV-AX80928CL, MV-AX81032CL, MV-AX81238CL, MV-AX81434CL, MV-AX81639CL, and MV-AX82040CL, 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

    274 of 274 codes

    • 45-781032 - 1903065Z8
    • 1903085Z8
    • 1903155Z8
    • 1903205Z8
    • 1903225Z8
    • 1904015Z8
    • 1904055Z8
    • 1904085Z8
    • 1904155Z8
    • 1904245Z8
    • 1904265Z8
    • 1904295Z8
    • and 1905155Z8
    • 45-781238 - 1903115Z8
    • 1903135Z8
    • 1903205Z8
    • 1904105Z8
    • 1904155Z8
    • 1904295Z8
    • and 1905065Z8
    • 45-781434 - 1903115Z8
    • 1903155Z8
    • 1904015Z8
    • 1904105Z8
    • 1904155Z8
    • and 1905155Z8
    • 45-781639 - 1903155Z8
    • 1903185Z8
    • and 1904015Z8
    • 45-781836 - 1903065Z8
    • 1903115Z8
    • 1903205Z8
    • 1903225Z8
    • 1904015Z8
    • 1904085Z8
    • 1904155Z8
    • and 1905155Z8
    • 45-782040 - 1903045Z8
    • 1903115Z8
    • 1903185Z8
    • 1904015Z8
    • 1904055Z8
    • 1904155Z8
    • 1905035ZA
    • 1905065Z8
    • 1905085Z8
    • and 1905155Z8
    • 45-780202 - 1903115Z8
    • 1903135Z8
    • 1903185Z8
    • 1904055Z8
    • 1904085Z8
    • 1904175ZA
    • 1904225Z8
    • 1904245Z8
    • 1904265Z8
    • 1904295Z8
    • 1905135Z8
    • and 1905205Z8
    • 45-780204 - 1903045Z8
Amount recalled
3,881 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.

Want the full recall guide?

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, 5:31 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.