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.
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 fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Microvention, Inc. is recalling 19 units of the Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil. The specific reference numbers involved are 45-651026 and 45-652050. The devices are sterile and require a prescription. The firm name on the label is MicroVention, Inc., Tustin, CA, and the distributor is Terumo Medical Corporation, Somerset, NJ. The devices were made in Costa Rica.
The recall is being issued because the devices may be missing the implant coil. This is a Class II recall, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The devices were distributed to Maryland in the United States. There was no direct military or government distribution. Foreign distribution was made directly to Belgium, Japan, Australia, Argentina, and Mexico. The specific catalog and lot numbers affected are 45-651026 (lots 19030655Y, 19041556W, and 19051058A) and 45-652050 (lots 19030654Y and 19041556X). Healthcare providers and patients should contact the manufacturer or distributor for further instructions regarding the return or replacement of these devices.
The recalled product
- 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.
- Manufacturer
- Microvention, Inc.
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 19
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 (4)
- Catalog/lot numbers: 45-651026 - 19030655Y
- 19041556W
- and 19051058A
- and 45-652050 - 19030654Y and 19041556X.
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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