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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91006

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

Open FDA event record

Event summary

Timeline bucket
September 30, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
LeMaitre Vascular, 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

TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..

Z-0228-2023
Recall number
Z-0228-2023
Initiated
September 30, 2022
Classification
Class II
Status
Ongoing
Recalling firm
LeMaitre Vascular, Inc.
Quantity
72 (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of the tip breaking off, and potentially becoming lost in the blood vessel.

Code information

Lots XSL0097, XSL0098, and XSL0099

Distribution pattern

No US distribution. Foreign distribution to United Kingdom, Germany, France, Sweden, Austria, and Italy.