AZUR CX 35 Peripheral Coil System Detachable Recalled for Unsealed Pouch Packaging
MicroVention is recalling 14 units of the AZUR CX 35 Peripheral Coil System due to unsealed pouch packaging that could compromise device sterility. The affected units were distributed across eight states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Unsealed packaging on a sterile medical device poses a potential contamination risk to patients. This qualifies as a high-risk product where injury has not yet been reported.
Plain-English summary
MicroVention Inc. is recalling 14 units of the AZUR CX 35 Peripheral Coil System Detachable (13mm x 24 cm, REF 45-751324) due to a potential issue with unsealed pouch packaging.
The peripheral coil system is designed to be sterile. Unsealed pouch packaging compromises the device's sterility, potentially allowing contamination.
The affected units were distributed nationwide in Texas, New York, Virginia, Nevada, Michigan, California, Arizona, and Washington. The recalled lot is 0000190693 with an expiration date of April 30, 2027 (UDI-DI: 00812636021089).
Facilities and healthcare providers should not use this product on patients.
The recalled product
- Product
- AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
- Manufacturer
- MICROVENTION INC.
- Affected units
- 14
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 (3)
- UDI-DI: 00812636021089
- Lot: 0000190693
- Expiration: 4/30/2027
Distribution
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