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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74880

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 03, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
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

3 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 3

1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves

Z-2543-2016
Recall number
Z-2543-2016
Initiated
August 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
1992 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable

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

Wire which deploys the loop may be come detached at the handle causing the device to be inoperable

Code information

Lot Number Exp Date ELVH1072V 2020-07 ELVH1082V 2021-01 ELVH1083V 2021-01 ELVH1084V 2021-02 ELVH1085V 2021-02 ELVH1086V 2021-02 ELVH1087V 2021-02 ELVH1088V 2021-03

Distribution pattern

Worldwide Distribution -  US Nationwide and in the countries of Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.

device · product 2 of 3

1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves

Z-2544-2016
Recall number
Z-2544-2016
Initiated
August 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
380 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable

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

Wire which deploys the loop may be come detached at the handle causing the device to be inoperable

Code information

Lot Number Exp Date ELVH1078V¿ 2020-10 ELVH1079VA 2020-10

Distribution pattern

Worldwide Distribution -  US Nationwide and in the countries of Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.

device · product 3 of 3

1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves

Z-2545-2016
Recall number
Z-2545-2016
Initiated
August 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
LeMaitre Vascular, Inc.
Quantity
50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable

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

Wire which deploys the loop may be come detached at the handle causing the device to be inoperable

Code information

Lot Number Exp Date ELVH1089V¿ 2021-03 ELVH1091V 2021-03¿

Distribution pattern

Worldwide Distribution -  US Nationwide and in the countries of Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.