Health product recall

Endurant Iis Stent Graft System

Brand(s)
Last updated

Summary

Product
Endurant Iis Stent Graft System
Issue
Medical devices - Manufacturing defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or serial number

Model or catalog number

Endurant Iis Stent Graft System

More than 10 numbers, contact manufacturer.

ESBF3214C103EE, ESBF2314C103EE, ESBF2814C103EE, ESBF2514C103EE

Endurant Ii Stent Graft System

More than 10 numbers, contact manufacturer.

ETCF2828C49EE, ETTF2323C70EE, ETBF2313C166EE, ETBF2513C145EE, ETBF2516C124EE, ETUF2814C102EE, ETBF2513C124EE, ETUF2514C102EE, ETBF2816C145EE, ETBF2813C124EE, ETCF2323C49EE, ETBF2516C166EE, ETBF2813C145EE, ETBF2813C166EE, ETBF2816C166EE, ETUF2314C102EE, ETBF2313C145EE, ETBF2316C166EE, ETBF2516C145EE, ETBF2820C145EE, ETCF2525C49EE, ETUF3614C102EE

Issue

Devices built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable. As of 09-Dec-2021, Medtronic has received five (5) complaints where the taper tip detached from the delivery system during the procedure. In three (3) cases the tip was retrieved successfully: One (1) through surgical conversion and two (2) by snaring. in the remaining two (2) cases the tip was intentionally left behind. No deaths have been reported from the five (5) complaints.

Recall start date: Dec 23, 2021

Additional information

Details
Original published date: 2022-01-20
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Companies
Medtronic Inc.

710 Medtronic Parkway N.E., Minneapolis, Minnesota

United States, 55432

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63821