Class II — Potential Health Hazard

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

Stryker Neurovascular Recalled by Stryker Neurovascular Due to Labeling error; 8F Balloon Guide Catheters have been...

Date: November 13, 2018
Company: Stryker Neurovascular
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 Stryker Neurovascular directly.

Affected Products

Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771

Quantity: 190 catheter guides

Why Was This Recalled?

Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging

Where Was This Sold?

OUS distribution only: CZECH REPUBLIC, ITALIA, Netherlands, Sweden, Germany, Austria, Israel, France, Belgium, Finland, Switzerland, Portugal, Finland

About Stryker Neurovascular

Stryker Neurovascular has 108 total recalls tracked by RecallDetector.

Related Recalls

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