FDAFDA · Food and drugs·Recall number Z-1760-2025
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Published May 28, 2025 · Recall initiated: April 11, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Centerline Biomedical Inc
- Distributor
- US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
- Lot
- UDI/DI 00843152102037, Lot Number 2404-2005
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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