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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77880

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 07, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Microvention, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-3103-2017
Recall number
Z-3103-2017
Initiated
August 07, 2017
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
34 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot numbers 17030521, 17032821, and 17041831

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.