The Recall Desk
HighFDA (Devices)·Z-0292-2022·Announced 2021-12-01

Medtronic Endurant IIs stent graft recalled due to spindle detachment risk

Medtronic recalls 419 Endurant IIs stent grafts due to risk of spindle detachment from the hypotube during deployment.

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: FDA Class II recall with no reported illnesses or injuries. The spindle detachment hazard presents a risk of device malfunction, but absence of reported adverse events supports classification as High severity, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medtronic Vascular, Inc. is recalling the Endurant IIs Stent Graft System, affecting 419 devices. The recall is due to a potential defect: during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

The recalled devices have various model numbers including ESBF2814C103EE, ESBF2814C103EJ, ESBF2314C103E, ESBF2314C103EE, ESBF2814C103E, and ESBF2514C103E. The devices were distributed worldwide, including to facilities in 16 U.S. states and 29 countries including Austria, Belgium, China, France, Germany, Italy, Japan, Spain, Sweden, Switzerland, and the United Kingdom.

The FDA classified this as a Class II recall. The recall number is Z-0292-2022. Anyone with questions about whether they received one of the affected devices should contact the healthcare facility where the device was obtained.

The recalled product

Product
Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF281
Manufacturer
Medtronic Vascular, Inc.
Category
Medical Device — Vascular Graft
Hazard
Affected units
419

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Medtronic Vascular, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

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