Centerline Biomedical Inc recalls Centerline Biomedical IOPS Guidewire 2

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

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

Centerline Biomedical issued an "URGENT MEDICAL DEVICE RECALL" notice dated 4/11/2025 to its consignees on 04/11/2025 via hand delivery. The notice explained the issue with the device, potential risk to the patient and actions to be taken. The consignees were requested to Complete the Customer Acknowledgement letter in the possession of your Clinical Account Manager and return all affected products to Clinical Account Manager. For questions contact: Director Quality and Regulatory, Phone Number: (330) 577-5033, Email: kevin.reed@centerlinebiomedical.com.

• FDA enforcement recordOfficial FDA database entry for Z-1760-2025
• FDA 510(k) clearance · K190106The device's official FDA premarket clearance record
• FDA 510(k) clearance · K230309The device's official FDA premarket clearance record
• FDA 510(k) clearance · K241243The device's official FDA premarket clearance record
• FDA 510(k) clearance · K242133The device's official FDA premarket clearance record
• FDA 510(k) clearance · K243842The device's official FDA premarket clearance record
• FDA device classification · DQKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1425The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Centerline Biomedical IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.