Class II — Potential Health Hazard

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

Angio-Seal Evolution Vascular Closure Device Recalled by Terumo Medical Corp Due to Two lots of product were released for distribution...

Date: April 9, 2018
Company: Terumo Medical Corp
Status: Terminated
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 Terumo Medical Corp directly.

Affected Products

Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135

Quantity: 240

Why Was This Recalled?

Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.

Where Was This Sold?

This product was distributed to 12 states: AL, CA, FL, IN, IA, MI, MO, NY, NC, SD, TN, TX

Affected (12 states)Not affected

About Terumo Medical Corp

Terumo Medical Corp has 20 total recalls tracked by RecallDetector.

Related Recalls

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