Class II

Medical Device Recall: TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

MICROVENTION INC. · December 21, 2023

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.

States Affected

NATIONWIDE

Quantity Affected

22 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0868-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.