Medtronic Recalls Endurant Bifurcated Stent Grafts Due to Fabric Permeability
Medtronic is voluntarily recalling specific Endurant and Endurant II bifurcated stent graft systems because fabric permeability variations may be associated with endoleaks during initial implant procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (endoleaks) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Vascular, Inc. is initiating a voluntary urgent medical device recall for a subset of Endurant and Endurant II 23mm and 25mm Bifurcated Stent Graft Systems. The recall affects 3,331 devices with specific model numbers and serial numbers listed in the official FDA record.
The recall is being conducted because this specific subset of stent grafts has a greater susceptibility to fabric permeability variations. These variations may be associated with endoleaks observed during the initial implant procedure. The devices are intended to treat infra-renal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
The affected devices were distributed worldwide, including the United States, Puerto Rico, and numerous international countries. Healthcare providers and patients should consult the FDA recall record for the specific serial numbers and model numbers involved in this recall.
The recalled product
- Product
- Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166E ETBF2313C124E ETBF2513C145E ETBF2516C124E ETBF2316C124E ETBF2513C124E. Cardiology:
- Manufacturer
- Medtronic Vascular, Inc.
- Category
- Medical Device — Cardiology
- Affected units
- 3,331
Distribution
Distributed in 1 state:
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