Reported Feb 19, 2020 · Terminated

Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039,…

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 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, MV-AX50511CD, MV-AX50617CD, MV-AX50824CD, and MV-AX51019CD, 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

    89 of 89 codes

    • 45-751019 - 1903045J2
    • 1903065J2
    • 1903085J2
    • 1904155J2
    • 1904175J2
    • 1904265J2
    • 1904295J2
    • 1905035J2
    • 1905085J2
    • 1905105K2
    • and 1905135J2
    • 45-751324 - 1903045J2
    • 1903155J2
    • 1903205J2
    • 1903225J2
    • 1904155J2
    • 1904225J2
    • 1904265J2
    • 1904295J2
    • 1905065J2
    • and 1905085J2
    • 45-751632 - 1903045J2
    • 1903065J2
    • 1903205J2
    • 1903225J2
    • 1904175J2
    • 1904265J2
    • 1904295J2
    • 1905035J2
    • 1905065J2
    • and 1905085J2
    • 45-752039 - 1903045J2
    • 1903205J2
    • 1904265J2
    • 1905035J2
    • and 1905065J2
    • 45-750407 - 1903045J2
    • 1903065J2
    • 1903085J2
    • 1903115J2
    • 1903155J2
    • 1904175J2
    • 1904175K2
    • 1904225J2
    • 1904245J2
    • 1904265J2
    • and1904295J2 45-750511 - 1903045J2
    • 1903065J2
    • 1903085J2
    • 1903155J2
    • 1904175J2
    • 1904175K2
    • 1904225J2
    • 1904245J2
    • 1904265J2
    • 1904295J2
    • 45-750617 - 1903045J2
    • 1903065J2
    • 1903085J2
    • 1903155J2
Amount recalled
1,187 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, 4:53 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.