TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
- Company
- Microvention Inc.
- Recall Initiated
- December 21, 2023
- Posted
- January 31, 2024
- Recall Number
- Z-0868-2024
- Quantity
- 22 units
- Firm Location
- Aliso Viejo, CA
Reason for Recall
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Distribution
U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
Lot / Code Info
Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047
Root Cause
Device Design
Action Taken
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