Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 Recalled by MICROVENTION INC. Due to Due to, during the manufacturing process, the prescribed...

Date: December 21, 2023
Company: MICROVENTION INC.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact MICROVENTION INC. directly.

Affected Products

TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

Quantity: 22 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About MICROVENTION INC.

MICROVENTION INC. has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report