Pruitt Irrigation Occlusion Catheter e2102-09Recalls & reported problems

Lemaitre Vascular, Inc. · Pruitt Irrigation Occlusion Catheter, 9F, eIFU · Class 2

All models of Pruitt Irrigation Occlusion Catheter (2)

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K880231); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Apr 11, 2025Class IIOpen, Classified
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Z-1751-2025 · Root cause: Packaging process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K880231. One submission often covers many models, so check the product and lot details in each record.

Z-1752-2025 · Apr 11, 2025 · Open, Classified
Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

Device details

UDI-DI	`00840663101542`
Brand	Pruitt Irrigation Occlusion Catheter
Model	e2102-09
Company	Lemaitre Vascular, Inc.
Product code	DQT · Occluder, Catheter Tip
Class	Class 2
FDA submission	K880231
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

Pruitt Irrigation Occlusion Catheter 2102-09
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1 recall4 reports
Pruitt Aortic Occlusion Catheter 2100-12
Lemaitre Vascular, Inc. · Occluder, Catheter Tip
6 reports
Polyurethane Dual Lumen Occlusion Catheter 5F-2L-40
Lemaitre Vascular, Inc. · Occluder, Catheter Tip
1 report

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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
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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