FDA recall Z-3103-2017

Product

MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.

Reason for recall

There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2017-08-07

Report date

2017-09-13

Termination date

2018-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3103-2017