Public recall detail

TufTex® Embolectomy and Pruitt® Occlusion Catheters

2025-04-29

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Recall Safety notice
Quick summary

Quick summary: TufTex® Embolectomy and Pruitt® Occlusion Catheters. Date: 2025-04-29.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: TufTex® Embolectomy and Pruitt® Occlusion Catheters. Date: 2025-04-29.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandLemaitre Vascular, Inc.
ProductTufTex® Embolectomy and Pruitt® Occlusion Catheters
IssueMedical devices - Sterility
Recall classType II
IdentificationRA-77348

Affected products

ProductTufTex® 5F Plus Over-The-Wire Embolectomy Catheter
LotMore than 10 numbers, contact manufacturer.
ModelE1651-84 E1651-88
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionTufTex® 5F Plus Over-The-Wire Embolectomy Catheter
ProductPruitt® Occlusion Catheter
LotMore than 10 numbers, contact manufacturer.
Model2103-36 2103-46 2103-56
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPruitt® Occlusion Catheter
ProductPruitt® Irrigation Occlusion Catheter
LotMore than 10 numbers, contact manufacturer.
Model2102-09
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionPruitt® Irrigation Occlusion Catheter
ProductTufTex® Over-The-Wire Embolectomy Catheter
LotMore than 10 numbers, contact manufacturer.
Model1651-44 E1651-34 1651-38 E1651-38 E1651-44 1651-64 E1651-64 E1651-68 1651-34 E1651-48 E1651-78
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionTufTex® Over-The-Wire Embolectomy Catheter

Issue

During internal product testing, we observed some packages to have incomplete seals (sterile barrier). If the sterile barrier of the packaged device is broken, there is a risk of contamination of the device and subsequent risk of infection if used. Recall start date: April 10, 2025

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesLemaitre Vascular, Inc. 63 Second Avenue, Burlington, Massachusetts, United States, 01803
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77348
Background{}
CompaniesLemaitre Vascular, Inc. 63 Second Avenue, Burlington, Massachusetts, United States, 01803
AudiencesHealthcare
Source updated2025-04-29

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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