The Recall Desk
HighFDA (Devices)·Z-1220-2020·Announced 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.

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 even though specific injuries are not reported in the source text.

Plain-English summary

Microvention, Inc. is recalling 445 units of the Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System. The recall is being conducted 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, as well as 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 various reference numbers, including 45-481015, 45-481020, and others listed in the agency's documentation.

Healthcare providers and facilities that have received these devices should check their inventory for the specific catalog and lot numbers listed in the recall notice. If the devices are found, they should be removed from use and returned to the recalling firm or the distributor as instructed. Patients who have already received these implants should contact their healthcare provider for guidance.

The recalled product

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, 45
Manufacturer
Microvention, Inc.
Category
Medical Device — Neurovascular Embolization
Hazard
Affected units
445

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: 45-481015 - 19031155A
  • 45-481020 - 19031355E and 190424567
  • 45-481215 - 19031154K and 19041554Z
  • 45-481220 - 19051357G
  • 45-481515 - 19041554W and 19041556Q
  • 45-481520 - 19032053A
  • 45-482020 - 190320539 and 19040855Y
  • 45-482030 - 19040855X
  • 45-480202 - 19032054J and 190506581
  • 45-480204 - 19051357N
  • 45-480310 - 19031154N
  • 19031355G
  • 190401554
  • and 19050657X
  • 45-480302 - 19050657V and 19051357P
  • 45-480305 - 19031154L
  • 19031354G
  • 19031355F
  • 19042254K
  • 19042453J

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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