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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80831

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

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Event summary

Timeline bucket
August 10, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Micro Therapeutics Inc, Dba Ev3 Neurovascular

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

ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.

Z-3022-2018
Recall number
Z-3022-2018
Initiated
August 10, 2018
Classification
Class II
Status
Terminated
Quantity
67 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Distal Flush Tool (DFT) accessories that were packaged in this lot number are not compatible with the TurboHawk LX-C catheter. This may result in the inability to remove excised material from the tip of the catheter.

Code information

Lot Number A495368

Distribution pattern

Distribution to US states of KS, CA, FL, GA, AZ, MI, LA, TX, NE, KY, and China