Recall Z-3103-2017— Microvention, Inc.

Name: FDA recall Z-3103-2017
Creator: U.S. Food and Drug Administration
Published: 2017-08-07

Class II · Terminated

Class II FDA medical device recall by Microvention, Inc., initiated 2017-08-07, terminated 2018-10-26. It names one FDA 510(k) clearance: K161803. 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..

Recalling firm: Microvention, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-07
Terminated: 2018-10-26
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K161803 — Traxcess .007 Mini GuidewireMicroVention, Inc.·cleared 2016-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.