MICROVENTION INC.: AZUR CX 35 Peripheral Coil System Recalled for Potential Unsealed Packaging

Agency Publication Date: October 27, 2023

Summary

MICROVENTION INC. is recalling 14 units of the AZUR CX 35 Peripheral Coil System Detachable (13mm x 24 CM) because the pouch packaging may not be properly sealed. This medical device is a specialized coil used in vascular procedures, and a compromised seal means the device may no longer be sterile. These affected units were distributed nationwide to medical facilities in Texas, New York, Virginia, Nevada, Michigan, California, Arizona, and Washington.

Risk

An unsealed pouch compromises the sterile barrier of the medical device, which can lead to serious infections or other complications if the non-sterile coil is used during a surgical procedure.

What You Should Do

Immediately check your medical inventory for the AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM (REF: 45-751324).
Verify if your product matches Lot number 0000190693, UDI-DI: 00812636021089, and an Expiration date of 4/30/2027.
If you identify an affected unit, do not use the device and set it aside to prevent accidental use.
Contact your healthcare provider or the manufacturer, MICROVENTION INC., at their Aliso Viejo, California headquarters for instructions on returning the product and obtaining a replacement or refund.
For further questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Device Return

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324

Model / REF:

REF: 45-751324

UPC Codes:

00812636021089

Lot Numbers:

0000190693 (Exp 4/30/2027)

Date Ranges: Expiration: 4/30/2027

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93147

Status: Active

Manufacturer: MICROVENTION INC.

Sold By: Medical facilities; Specialty healthcare providers

Manufactured In: United States

Units Affected: 14

Distributed To: Texas, New York, Virginia, Nevada, Michigan, California, Arizona, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Immediately check your medical inventory for the AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM (REF: 45-751324).

Verify if your product matches Lot number 0000190693, UDI-DI: 00812636021089, and an Expiration date of 4/30/2027.

If you identify an affected unit, do not use the device and set it aside to prevent accidental use.

Contact your healthcare provider or the manufacturer, MICROVENTION INC., at their Aliso Viejo, California headquarters for instructions on returning the product and obtaining a replacement or refund.

For further questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.