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.
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. The hazard involves a missing component in a sterile medical device, which poses a risk of harm if the device is used without the necessary implant coil, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
MicroVention, Inc. is recalling 107 units of the Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil. The recall is due to a defect where the devices may be missing the implant coil. The affected reference numbers are 45-681026, 45-681434, 45-682050, and 45-680820.
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 specific lot numbers associated with the recall are listed in the agency's structured data.
Healthcare providers and facilities should check their inventory for these specific reference and lot numbers. If the devices are found, they should be removed from use and returned to the recalling firm according to their instructions. Patients who have already received the device should contact their healthcare provider for guidance.
The recalled product
- 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.
- Manufacturer
- Microvention, Inc.
- Category
- Medical Device — Neurovascular
- Affected units
- 107
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 (15)
- Catalog/lot numbers: 45-681026 - 1903085J5
- 1903155J5
- and 1904035J5
- 45-681434 - 1903015J5
- and 1904155J5
- 45-682050 - 1903085K5
- 1903135J5
- 1904015J5
- 1904155J5
- 1904175J5
- and 1905105K5
- and 45-680820 - 1903045J5
- 1903085K5
- 1904035J5
- and 1904155J5.
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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