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Endurant II Stent Graft System
- Starting date:
- March 9, 2017
- Posting date:
- April 4, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-62896
Reason
This specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure. At the time of implant procedure this permeability variation may cause the physician to categorize a type IV endoleak (which typically self-resolves over time) as an acute type ill fabric endoleak because the leak may appear to be focal or a localized leak as opposed to a diffused leak (blush). The misclassification as an acute type ill fabric endoleak may lead to unnecessary secondary interventions.
Affected products
Endurant II Stent Graft System
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
ETBF2313C124EE
ETBF2313C145EE
ETBF2313C166EE
ETBF2316C124EE
ETBF2316C145EE
ETBF2316C166EE
ETBF2513C124EE
ETBF2513C145EE
ETBF2513C166EE
ETBF2516C124EE
ETBF2516C145EE
ETBF2516C166EE
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES