The Recall Desk
HighFDA (Devices)·Z-1225-2020·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a missing critical component in a medical device, which poses a risk of harm if the device is used without the implant coil, even though no specific injuries are reported in the source text.

Plain-English summary

Microvention, Inc. is recalling 1,187 units of the Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil. The recall was initiated because the devices may be missing the implant coil. The affected products are sterile, prescription-only medical devices manufactured in Costa Rica and distributed by Terumo Medical Corporation.

The devices were distributed to Maryland in the United States and directly to Belgium, Japan, Australia, Argentina, and Mexico. There was no direct military or government distribution. The recall covers specific catalog and lot numbers associated with 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.

Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Patients who have already received an implant should contact their healthcare provider to verify that the correct components were used during the procedure.

The recalled product

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 fi
Manufacturer
Microvention, Inc.
Category
Medical Device — Neurovascular
Hazard
Affected units
1,187

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Catalog/lot numbers: 45-751019 - 1903045J2
  • 1903065J2
  • 1903085J2
  • 1904155J2
  • 1904175J2
  • 1904265J2
  • 1904295J2
  • 1905035J2
  • 1905085J2
  • 1905105K2
  • and 1905135J2
  • 45-751324 - 1903045J2
  • 1903155J2
  • 1903205J2
  • 1903225J2
  • 1904225J2
  • 1905065J2
  • and 1905085J2
  • 45-751632 - 1903045J2
  • 45-752039 - 1903045J2

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 6 recalled by Microvention, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Microvention, Inc.

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Same hazard · missing component

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