MICROVENTION INC.: Medical Device Recall in 2024 - (Recall #: Z-0868-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

Product Classification:

Class II

Date Initiated: December 21, 2023

Date Posted: February 7, 2024

Recall Number: Z-0868-2024

Event ID: 93692

Reason for Recall:

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

Status: Ongoing

Product Quantity: 22 units

Code Information:

Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated