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Centerline Biomedical Inc recalls Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate pl
Recalled May 28, 2025 · FDA recall Z-1760-2025 · Centerline Biomedical
Hazard
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire. · FDA Class I
Units
80 units
Sold at
US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
Description
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Product
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Manufacturer(s)
Centerline Biomedical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →