Medtronic Vascular, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2135-2021)

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:

Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. 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-2135-2021

Event ID: 88158

Reason for Recall:

During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

Status: Ongoing

Product Quantity: 18 devices

Code Information:

Endurant II Stent Graft System: Model (REF): ETCF3636C49EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3214C102EE GTIN: 00643169780958 Serial Numbers: V29775791; V29775792; V29775793; V29775794; V29775795; Model (REF): ETBF3216C166EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3614C102E GTIN: 00643169232631 Serial Numbers: V29781886 V29781883 V29781889 V29781887 V29781890 V29781891 V29781882

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