RecallRadar

FDA Device recall Z-3103-2017

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

On 2017-09-13 the FDA classified a Class II recall of MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX by Microvention, citing there is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-3103-2017
ClassificationClass II
Statusterminated
Initiated2017-08-07
Published2017-09-13
Last updated2026-09-13 11:54 UTC
CompanyMicrovention
DistributionAZ, CA, CO, MA, MI, MN, MO, NY, OH, UT, VA, WI

Product

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

Reason

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

Identifiers

code_infoLot numbers 17030521, 17032821, and 17041831

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3103-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.