The Recall Desk

FDA (Devices) recall action 84585

Microvention, Inc. recalled 6 products on 2020-02-19

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2020-02-19
Critical
0
Units
6,031

Why these products were recalled

The devices may be missing the implant coil.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–6 of 6

  • HighFDA (Devices)··2020-02-19

    Terumo AZUR CX Peripheral Coil System Recalled for Missing Implant Coil

    Microvention, Inc. is recalling 3,881 units of the Terumo AZUR CX Peripheral Coil System because the devices may be missing the implant coil.

    Product
    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…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2020-02-19

    Terumo AZUR Peripheral Coil System Recalled for Missing Implant Coil

    Microvention, Inc. is recalling 445 units of Terumo AZUR Peripheral Coil Systems because the implant coil may be missing from the device.

    Product
    Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, 45-480204, 45-480310, 45-480302, 45-480305, 45-480410, 45-480415, 45-480420…
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2020-02-19

    Microvention AZUR Peripheral Coil System Recall for Missing Implant Coil

    Microvention is recalling 392 units of AZUR Peripheral Coil Systems because the implant coil may be missing from the devices.

    Product
    Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815…
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2020-02-19

    MicroVention AZUR Peripheral Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 107 units of the AZUR Peripheral Coil System because the implant coil may be missing from the sterile packaging.

    Product
    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 By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2020-02-19

    Terumo AZUR Peripheral Coil System Recalled for Missing Implant Coil

    Microvention, Inc. is recalling 19 units of Terumo AZUR Peripheral Coil Systems because the implant coil may be missing from the device.

    Product
    Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2020-02-19

    Terumo AZUR CX Peripheral Coil System Recalled for Missing Implant Coil

    Microvention is recalling 1,187 units of Terumo AZUR CX Peripheral Coil Systems because the implant coil may be missing from the packaging.

    Product
    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…
    Category
    Distribution
    1 state