FDA Medical Device Recalls (openFDA)
MICROVENTION INC.: TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
- Recall number
- Z-0868-2024
- Recalling firm
- MICROVENTION INC.
- Product
- TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
- Status
- Open, Classified
- Initiated
- 2023-12-21
- Posted
- 2024-01-31
- Terminated
- not on file
- Reason
- Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
- Root cause
- 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
- 22 units
- Distribution
- U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
- Lot, serial or model codes
- Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047
- 510(k) numbers
- ["K150870","K192684"]
- PMA numbers
- not on file
- Product code
- NOY
- Firm FEI
- 3013556777
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28