Centerline Biomedical Inc recalls Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate p…

Recall date

April 11, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1760-2025

FDA classification

Class I

Brand / firm

Centerline Biomedical Inc

Sold / distributed

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

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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