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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). The missing implant coil represents a significant functional defect in a medical device.
Plain-English summary
Microvention, Inc. is recalling 392 units of the Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System. The recall is being conducted because the devices may be missing the implant coil.
The affected 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 listed in the agency's official documentation.
Healthcare providers and facilities that have received these devices should stop using them and contact Microvention, Inc. for instructions on how to return or replace the affected units. Patients who have already received an implant should contact their healthcare provider to discuss the potential impact of the missing coil.
The recalled product
- 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, 4
- Manufacturer
- Microvention, Inc.
- Category
- Medical Device — Neurovascular
- Affected units
- 392
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: 45-451015 - 190410589
- 45-451020- 19030456J
- 19041056C
- 19041756Y
- 190422549
- and 190422573
- 45-451215 -190410569
- 45-451220 -19040853N
- 45-451230 -19041554R
- 45-451520 -19030654N
- 190408565
- 190410588
- and 190422572
- 45-451530 -19030456L
- 190408569
- 19041056A
- 190415571
- 19041756Z
- 190417599
- 19042656G
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.
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