Health product recall

TufTex® Embolectomy and Pruitt® Occlusion Catheters

Last updated

Summary

Product
TufTex® Embolectomy and Pruitt® Occlusion Catheters
Issue
Medical devices - Sterility
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

TufTex® 5F Plus Over-The-Wire Embolectomy Catheter

More than 10 numbers, contact manufacturer.

E1651-84
E1651-88

Pruitt® Occlusion Catheter

More than 10 numbers, contact manufacturer.

2103-36
2103-46
2103-56

Pruitt® Irrigation Occlusion Catheter

More than 10 numbers, contact manufacturer.

2102-09

TufTex® Over-The-Wire Embolectomy Catheter

More than 10 numbers, contact manufacturer.

1651-44
E1651-34
1651-38
E1651-38
E1651-44
1651-64
E1651-64
E1651-68
1651-34
E1651-48
E1651-78

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Lemaitre Vascular, Inc.

63 Second Avenue, Burlington, Massachusetts, United States, 01803

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77348

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