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U.S. Department of Health and Human Services

Class 2 Device Recall HYDROPEARL Microspheres

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  Class 2 Device Recall HYDROPEARL Microspheres see related information
Date Initiated by Firm December 21, 2023
Date Posted January 31, 2024
Recall Status1 Open3, Classified
Recall Number Z-0868-2024
Recall Event ID 93692
510(K)Number K192684  K150870  
Product Classification Agents, embolic, for treatment of benign prostatic hyperplasia - Product Code NOY
Product TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Code Information Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047
Recalling Firm/
Manufacturer		 MICROVENTION INC.
35 Enterprise
Aliso Viejo CA 92656
For Additional Information Contact Terrence Callahan
949-899-7194
Manufacturer Reason
for Recall		 Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
FDA Determined
Cause 2		 Device Design
Action On 12/21/2023, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx Overnight Certified Letter to customers informing them that MicroVention is recalling one lot (#00003420470 of HYDRPEARL Microsphere Device (HP2S0600) due to the firm no following the prescribed manufacturing and quality processes and the affected product was inadvertently released for distribution. Specifically, the in-processing ageing step was mistakenly extended an additional five (5) days. Customers are instructed to: 1. Immediately stop using and quarantine the impacted HYDROPEARL device. 2. Inform all individuals with their organization of the recall and forward to any organizations that they may have received the affected products. 3. Complete the CUSTOMER ACKNOWLEDGEMENT FORM to gina.digioia@terumomedical.com 4. If their institution has any affected inventory, contact Customer Care at 800-888-3786 or email tmccustomer.admin@terumomedical.com to request a recall return and received RGA details to return the device(s). For questions or assistance, contact Director, Post-Market Surveillance at terrence.callahan@microvention.com
Quantity in Commerce 22 units
Distribution U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
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 = NOY and Original Applicant = MICROVENTION, INC.
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