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Terminated

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

FDA Recall Z-3103-2017 · Posted None

Recalling FirmMicrovention, Inc.
Recall StatusTerminated
Product CodeMOF
Date Initiated2017-08-07
Date Terminated2018-10-26
Product Quantity34 units

Reason for Recall

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

Firm Action

Letters dated 8/7/2017 were issued on 8/7/2017 via overnight mail to the direct account medical facilities.

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161803Traxcess .007 Mini GuidewireMicroVention, Inc. · 2016-09-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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