Class II — Potential Health Hazard

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

MISAGO RX Self Expanding Peripheral Stem Recalled by Terumo Medical Corp Due to During recent routine testing, the MISAGO Peripheral Stent...

Date: August 4, 2016
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

MISAGO RX Self Expanding Peripheral Stem

Quantity: 7,965 units

Why Was This Recalled?

During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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