The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2136-2021·Announced 2021-08-04

Medtronic Endurant IIs stent graft system marker detachment recall

Medtronic is recalling 21 Endurant IIs stent graft systems due to radiopaque marker bond detachment during device deployment. The defect could affect surgical visualization and device positioning.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 medical device recall affecting a structural component of a vascular implant used in life-critical surgery. No injuries or hospitalizations have been reported. The marker detachment presents a risk of harm by potentially impairing surgical visualization during device deployment.

Plain-English summary

Medtronic Vascular, Inc. is recalling 21 units of the Endurant IIs Stent Graft System (models ESBF3614C103EE and ESBF3214C103E). These devices are used to treat infrarenal abdominal aortic and aortoiliac aneurysms using an endovascular approach.

During product complaint investigation, the radiopaque marker bond was found to detach from the distal end of the graft cover during stent graft deployment. The radiopaque markers are used to help surgeons visualize the device during implantation.

The affected devices were distributed in the United States (Georgia, Massachusetts, Maryland, New York, South Carolina, Texas, Washington, and West Virginia) and internationally (Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland, and United Kingdom).

The recalled product

Product
Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
Manufacturer
Medtronic Vascular, Inc.
Category
Medical Device — Vascular Implant
Hazard
Affected units
21

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • V29780771
  • V29780759
  • Model (REF): ESBF3614C103EE GTIN: 00643169780460 Serial Numbers: V29781932
  • V29781933
  • V29781934
  • V29781935
  • V29781936
  • V29781937
  • V29781938
  • V29781939
  • V29781940
  • V29781941
  • V29781942
  • V29781943
  • V29781944
  • V29781945
  • V29781946
  • V29781947
  • V29781948
  • V29781951

Distribution

Distributed in 8 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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