medical Class I Updated 2025-05-28

Centerline Biomedical Inc recalls Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorize

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
Lot/Code Info: UDI/DI 00843152102037, Lot Number 2404-2005
View official government recall

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