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Recall Observatory FDA recall evidence

Device product

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

August 03, 2016

Class II

Product summary

Firm
LeMaitre Vascular, Inc.
Event
Event 74880
Status
Terminated
Classification
Class II
Quantity
1992 units
Official record key
device-enforcement:Z-2543-2016

Official wording

Reason: 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.

Derived failure modes

  • 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

Field note

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