Device product
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Z-1760-2025
Product summary
- Event
- Event 96697
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 80 units
- Official record key
device-enforcement:Z-1760-2025
Official wording
Reason: Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Code information: UDI/DI 00843152102037, Lot Number 2404-2005
Distribution pattern: US distribution to states of: Pennsylvania, Florida, Texas, New York, North Carolina, New Mexico, Virginia, Tennessee
Derived failure modes
-
Unknown
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.