Recall Z-0868-2024— MICROVENTION INC.

Name: FDA recall Z-0868-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-21

Class II · Ongoing

Class II FDA medical device recall by MICROVENTION INC., initiated 2023-12-21. It names 2 FDA 510(k) clearances: K192684, K150870. Product: TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600. Reason: Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed..

Recalling firm: MICROVENTION INC.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-21
Firm location: Aliso Viejo, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K192684 — HydroPearl MicrospheresMicroVention, Inc.·cleared 2020-01-22
K150870 — HydroPearl Microspheres, HydroPearl MicrospheresMicroVention, Inc.·cleared 2015-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.