Medtronic Vascular, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2136-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 7, 2021

Date Posted: August 4, 2021

Recall Number: Z-2136-2021

Event ID: 88158

Reason for Recall:

During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

Status: Ongoing

Product Quantity: 21 devices

Code Information:

Endurant IIs Stent Graft System: Model (REF):ESBF3214C103E GTIN: 00643169439962 Serial Numbers: V29780773; 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 Pattern:

U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated