Trivex SystemRecalls & reported problems across all models
Lemaitre Vascular, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 69
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of Trivex System by Lemaitre Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2017 and May 8, 2020 — classified as 69 malfunctions.
The most frequently reported specific device problem is “Failure to Conduct” (28 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Trivex System problems
Device problems
- Failure to Conduct28
- Electrical /Electronic Property Problem11
- Device Inoperable10
- 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 Patient41
- No Information20
- No Patient Involvement4
- Laceration(s)2
- No Consequences Or Impact To Patient2
- Vasculitis2
Trivex System models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Trivex System 7210387Stripper, Vein, External60 reports
- Trivex System 7210387FStripper, Vein, External6 reports
- Trivex System 7210386Stripper, Vein, External3 reports
Recent Trivex System adverse event reports
The 15 most recent reports across all models, 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, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
DURING PRE-USE CHECK, THE HANDPIECE FAILED TO OPERATE PROPERLY. THE BLADE ROTATED INTERMITTENTLY EVEN WHEN THE RUN BUTTON WAS NOT PRESSED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9714615 ↗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 ↗
Other Lemaitre Vascular, Inc. products
- LeMaitre Embolectomy Catheter47 models · 438 reports · 2 recalls
- Pruitt F3 Carotid Shunt10 models · 305 reports
- Artegraft Vascular Graft15 models · 25 reports · 3 recalls
- Syntel Silicone OTW Embolectomy Catheter8 models · 66 reports
- Syntel Silicone Thrombectomy Catheter5 models · 6 reports · 1 recall
- Pruitt Occlusion Catheter6 models · 5 reports · 1 recall
- Pruitt Irrigation Occlusion Catheter2 models · 4 reports · 1 recall
- LifeSpan ePTFE Vascular Graft10 models · 27 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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