Microvention, Inc.: Medical Device Recall in 2017 - (Recall #: Z-3103-2017)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2017.
Data Source: FDA.
Product Description:
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Product Classification:
Class II
Date Initiated: August 7, 2017
Date Posted: September 13, 2017
Recall Number: Z-3103-2017
Event ID: 77880
Reason for Recall:
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
Status: Terminated
Product Quantity: 34 units
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.
Voluntary or Mandated:
Voluntary: Firm initiated