Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vascu...
FDA Recall #Z-1760-2025 — Class I — April 11, 2025
Product Description
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Reason for Recall
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Recalling Firm
Centerline Biomedical Inc — Cleveland, OH
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
80 units
Distribution
US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
Code Information
UDI/DI 00843152102037, Lot Number 2404-2005
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated