Centerline Biomedical Inc: Device Recall
Recall #Z-1760-2025 · 04/11/2025
Class I: Dangerous
Recall Details
- Recall Number
- Z-1760-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Centerline Biomedical Inc
- Status
- Ongoing
- Date Initiated
- 04/11/2025
- Location
- Cleveland, OH, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 units
Reason for Recall
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Product Description
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Distribution Pattern
US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.