Polyurethane Dual Lumen Occlusion Catheter 5F-2L-40Recalls & reported problems

Lemaitre Vascular, Inc. · Polyurethane Dual Lumen Occlusion Catheter, 5F, 40cm · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663102273), received between Dec 23, 2019 and Dec 23, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Burst Container or Vessel1

Patient problems

No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryDec 23, 2019Burst Container or Vessel; Burst Container or Vessel
DURING DECLOTTING, THE BALLOON OF THE DUAL LUMEN OCCLUSION CATHETER RUPTURED WHEN IT WAS PULLED OUT OF THE ARTERIAL SITE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THE INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9512435 ↗

Device details

UDI-DI	`00840663102273`
Brand	Polyurethane Dual Lumen Occlusion Catheter
Model	5F-2L-40
Company	Lemaitre Vascular, Inc.
Product code	DQT · Occluder, Catheter Tip
Class	Class 2
FDA submission	K844918
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 4, 2023

Device type (GMDN): Intravascular occluding balloon catheter, image-guided

A non-powered flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.

Other Occluder, Catheter Tip devices

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1 recall4 reports
Pruitt Irrigation Occlusion Catheter e2102-09
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1 recall0 reports
Pruitt Aortic Occlusion Catheter 2100-12
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6 reports

All Occluder, Catheter Tip devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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