Device product
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Z-3103-2017
Product summary
- Event
- Event 77880
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34 units
- Official record key
device-enforcement:Z-3103-2017
Official wording
Reason: There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
Code information: Lot numbers 17030521, 17032821, and 17041831
Distribution pattern: Distribution was made to medical facilities located in AZ, CA, CO, MA, MI, MN, MO, NY, OH UT, VA, and WI. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.