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Trivex System 7210386Recalls & reported problems

Lemaitre Vascular, Inc. · Trivex System control unit with build in pump · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840663106530), received between Oct 11, 2018 and Feb 7, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Conduct” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K032387); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Failure to Conduct2
  • Electrical /Electronic Property Problem1

Patient problems

  • No Known Impact Or Consequence To Patient3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 7, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    DURING TRANSILLUMINATED POWERED PHLEBECTOMY (TIPP), THE CONTROL UNIT STOPPED WORKING PERIODICALLY FLASHING ORANGE LIGHT ON THE CONTROL UNIT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8318309 ↗
  • MalfunctionDec 19, 2018Failure to Conduct; Failure to Conduct

    DURING TRANSILLUMINATED POWERED PHLEBECTOMY SURGERY (TIPP), THE HANDPIECE FAILED TO OPERATE SINCE IT COULD NOT MAKE A PROPER CONNECTION WITH THE CONTROL UNIT. AS A RESULT, SURGEON HAD TO POSTPONE THE PROCEDURE TO A LATER TIME SINCE THEY DID NOT HAVE ANY OTHER CONTROL UNIT IN STOCK AT THAT TIME TO COMPLETE THE PROCEDURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8181195 ↗
  • MalfunctionOct 11, 2018Failure to Conduct; Failure to Conduct

    DURING PRE-USE CHECK, THE HANDPIECE FAILED TO OPERATE WHEN IT WAS CONNECTED TO THE CONTROL UNIT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7957433 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032387. One submission often covers many models, so check the product and lot details in each record.

  • Z-1105-2007 · Oct 12, 2004 · Terminated
    Smith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.

Other Stripper, Vein, External devices

All Stripper, Vein, External devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.