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Trivex System

Lemaitre Vascular, Inc. · Model 7209791 · UDI-DI 00840663106554

DWQ Prescription
1
510(k) clearances
106
Adverse events (1 deaths)
2
Recalls
8
Facilities

Description

TRIVEX System footswitch

Recalls

DateFirmReason
2015-02-24LeMaitre Vascular, Inc.Mislabeled with an incorrect expiration date
2004-10-12Smith & Nephew, Inc Endoscopy DivisionBuild-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.