Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AZURTM CX 35 Peripheral Coil System Detachable 13mm x 24 CM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall AZURTM CX 35 Peripheral Coil System Detachable 13mm x 24 CM see related information
Date Initiated by Firm August 24, 2023
Date Posted October 27, 2023
Recall Status1 Open3, Classified
Recall Number Z-0187-2024
Recall Event ID 93147
510(K)Number K151358  
Product Classification Device, Vascular, for Promoting Embolization - Product Code KRD
Product AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Code Information UDI-DI: 00812636021089, Lot: 0000190693, Expiration: 4/30/2027
Recalling Firm/
Manufacturer		 MICROVENTION INC.
35 Enterprise
Aliso Viejo CA 92656
For Additional Information Contact Terrence Callahan
949-899-7194
Manufacturer Reason
for Recall		 Peripheral coil system detachable has a potential of unsealed pouch packaging.
FDA Determined
Cause 2		 Process control
Action On 8/22/23, recall notices were mailed to customers, who were asked to do the following: 1) Stop using, quarantine, and return affected devices to the firm. 2) Complete and return the customer acknowledgement form via email to recalls@microvention.com. Inquires can be directed to customer service at 800-990-8368
Quantity in Commerce 14
Distribution US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KRD and Original Applicant = Micro Vention, Inc.
-
-