Trivex System 7210387Recalls & reported problems
Lemaitre Vascular, Inc. · TRIVEX System Resector handpiece · Class 2
Quick summary
This Lemaitre Vascular Trivex System resector handpiece is a surgical tool used to remove tissue during vein procedures. The 60 reports mostly describe the handpiece failing to spin or stop working, often discovered during pre-use checks so the procedure was not started or completed; a few mention vein inflammation and cuts to the patient. No deaths or injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00840663106561), received between Apr 22, 2017 and May 8, 2020 — classified as 60 malfunctions.
The most frequently reported specific device problem is “Failure to Conduct” (21 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 Conduct21
- Device Inoperable10
- Electrical /Electronic Property Problem9
- Device Operational Issue4
- Device Stops Intermittently4
- No Device Output3
- Failure to Auto Stop2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Known Impact Or Consequence To Patient34
- No Information18
- No Patient Involvement4
- Laceration(s)2
- No Consequences Or Impact To Patient2
- Vasculitis2
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
DEVICE FAILED TO OPERATE DURING PRE-USE CHECK.
Patient problems: No Patient Involvement
MAUDE report 10039085 ↗MalfunctionFeb 14, 2020Defective Device
DURING PRE-USE CHECK, THE HANDPIECE FAILED TO OPERATE. DEVICE WAS NOT USED FOR THE PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9712014 ↗MalfunctionOct 24, 2019Power Problem; Power Problem
DURING PROCEDURE, THE RESECTOR OF THE HANDPIECE STOPPED SPINNING. HOWEVER, AFTER FEW ATTEMPTS, SURGEON WAS ABLE TO GET THE DEVICE TO WORK PROPERLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9235123 ↗MalfunctionAug 22, 2019Failure to Conduct; Failure to Conduct
DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT SPIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8923142 ↗MalfunctionAug 22, 2019Failure to Conduct; Failure to Conduct
DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT SPIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8923141 ↗MalfunctionAug 22, 2019Failure to Conduct; Failure to Conduct
DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT SPIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8923140 ↗MalfunctionAug 22, 2019Failure to Conduct; Failure to Conduct
DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT SPIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8923139 ↗MalfunctionMay 9, 2019No Device Output; No Device Output
THE RESECTOR FAILED TO ROTATE DURING PRE-USE CHECK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8597024 ↗MalfunctionMay 9, 2019No Device Output; No Device Output
THE RESECTOR FAILED TO ROTATE DURING PRE-USE CHECK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8597023 ↗MalfunctionMay 8, 2019No Device Output; No Device Output
THE RESECTOR FAILED TO ROTATE DURING PRE-USE CHECK.
Patient problems: No Information
MAUDE report 8593242 ↗MalfunctionMay 2, 2019Intermittent Loss of Power
SURGEON REPORTED THAT DURING THE TRANSILLUMINATED PHLEBECTOMY (TIPP) PROCEDURE, THE HANDPIECE WORKED INTERMITTENTLY. HE THEN SWITCHED TO ANOTHER HANDPIECE TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THE INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8573479 ↗MalfunctionApr 26, 2019Appropriate Device Problem Term/Code Not Available
DURING PRE-USE CHECK, THE HANDPIECE FAILED TO WORK.
Patient problems: No Information
MAUDE report 8558236 ↗MalfunctionApr 19, 2019Mechanics Altered
DURING TIPP ( TRANSILLUMINATED POWERED PHLEBECTOMY) PROCEDURE, THE RESECTOR FAILED TO ROTATE. SO, THE PROCEDURE WAS COMPLETELY USING A DIFFERENT HANDPIECE. THERE WAS NO INJURY OR ANY ADVERSE EVENT TO THE PATIENT AS THE RESULT OF THIS INCIDENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8532737 ↗MalfunctionApr 11, 2019Overheating of Device
DURING PRE-USE CHECK, THE HANDPIECE WAS OVERHEATING. DEVICE WAS NOT USED FOR THE TIPP PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8505541 ↗MalfunctionApr 3, 2019Failure to Read Input Signal; Unintended Movement
DURING PRE-USE CHECK, THE RESECTOR KEPT SPINING EVEN AFTER RELEASING THE BUTTON.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8480139 ↗MalfunctionMar 14, 2019Failure to Power Up; Failure to Power Up
HANDPIECE DID NOT OPERATE DURING PRE-USE CHECK.
Patient problems: No Information
MAUDE report 8422451 ↗MalfunctionMar 8, 2019Failure to Conduct; Failure to Conduct
DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT SPIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8405620 ↗MalfunctionMar 8, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
DURING PRE-USE CHECK, THE RESECTOR KEPT SPINNING EVEN AFTER RELEASING THE BUTTON.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8405616 ↗MalfunctionFeb 28, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
HANDPIECE DID NOT OPERATE DURING PRE-USE CHECK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8379087 ↗MalfunctionFeb 28, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
HANDPIECE DID OPERATE DURING PRE-USE CHECK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8379085 ↗MalfunctionFeb 28, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
HANDPIECE DID NOT OPERATE DURING PRE-USE CHECK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8379074 ↗MalfunctionJan 31, 2019Failure to Conduct; Failure to Conduct
DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT ROTATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8294529 ↗MalfunctionJan 18, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
HANDPIECE DID NOT OPERATE PROPERLY DURING PRE-USE CHECK. THE RESECTOR ON THE HANDPIECE STOPPED SPINNING AFTER A WHILE AND THE INDICATOR LIGHT FLASHED ORANGE ON THE CONTROL UNIT.
Patient problems: No Information
MAUDE report 8262582 ↗MalfunctionJan 10, 2019Failure to Conduct; Failure to Conduct
DURING PRE-USE CHECK, THE HANDPIECE FAILED TO OPERATE.
Patient problems: No Patient Involvement
MAUDE report 8232999 ↗MalfunctionJan 2, 2019Failure to Conduct; Failure to Conduct
DURING THE TRANSILLUMINATED POWERED PHLEBECTOMY PROCEDURE (TIPP), THE HANDPIECE STOPPED WORKING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8210315 ↗
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 · TerminatedSmith & Nephew TRIVEX System Pneumatic Footswitch, Part #7209791; distributed by Smith & Nephew, Inc. - Endoscopy, Andover, MA 01810.
Other Stripper, Vein, External devices
- Trivex System 7210387FLemaitre Vascular, Inc. · Stripper, Vein, External6 reports
- Trivex System 7210386Lemaitre Vascular, Inc. · Stripper, Vein, External3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.