TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

FDA device recall Z-0868-2024 · posted 2024-01-31 · Open, Classified

Recall details

Recalling firm

MICROVENTION INC.

Reason for recall

Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.

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

Root cause

Device Design

Status

Open, Classified

Product code

NOY

Quantity affected

22 units

Distribution

U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.

Date initiated

2023-12-21

Date posted

2024-01-31

Location

Aliso Viejo, CA

Related 510(k) clearances