Z-3103-2017Class II

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

Name: Z-3103-2017 MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per...
Creator: Microvention, Inc.
Published: 2017-08-07
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2017-08-07 / Terminated

FDA source

Microvention, Inc. began a recall of MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX on 2017-08-07. FDA classified it as Class II and gives the reason as "There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3103-2017
Classification: Class II
Status: Terminated
Initiated: 2017-08-07
Posted: 2017-09-01
Terminated: 2018-10-26
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Product code: MOF Guide, Wire, Catheter, Neurovasculature
Reason for recall: There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
FDA root cause: Under Investigation by firm
Action: Letters dated 8/7/2017 were issued on 8/7/2017 via overnight mail to the direct account medical facilities.
Quantity in commerce: 34 units
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.
Product codes and lots: Lot numbers 17030521, 17032821, and 17041831

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3103-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3103-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-13	2017-09-01

Product code MOF

K161803Class IITraxcess .007 Mini GuidewireMicroVention, Inc. / cleared 2016-09-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)