Z-1760-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 28, 2025
- Initiation Date
- April 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 units
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.
Distribution Pattern
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