Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Centerline Biomedical IOPS Guidewire 2 Recalled by Centerline Biomedical Inc Due to Centerline Biomedical has determined that the coating on...

Date: April 11, 2025
Company: Centerline Biomedical 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 Centerline Biomedical Inc directly.

Affected Products

Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter

Quantity: 80 units

Why Was This Recalled?

Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.

Where Was This Sold?

US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee

About Centerline Biomedical Inc

Centerline Biomedical Inc has 1 total recall tracked by RecallDetector.

Related Recalls

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