Z-0868-2024Class II

TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

Name: Z-0868-2024 TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Creator: Microvention Inc.
Published: 2023-12-21
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2023-12-21 / Open, Classified / root cause: design

FDA source

MICROVENTION INC. began a recall of TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 on 2023-12-21. FDA classified it as Class II and gives the reason as "Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0868-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-21
Posted: 2024-01-31
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Product code: NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Reason for recall: Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Root cause tag: design
FDA 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 [email protected] 4. If their institution has any affected inventory, contact Customer Care at 800-888-3786 or email [email protected] to request a recall return and received RGA details to return the device(s). For questions or assistance, contact Director, Post-Market Surveillance at [email protected]
Quantity in commerce: 22 units
Distribution: U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
Product codes and lots: Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0868-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0868-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31

Product code NOY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)