Z-2136-2021Class II

Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and...

Name: Z-2136-2021 Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and...
Creator: Medtronic Vascular, Inc.
Published: 2021-06-07
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-06-07 / Open, Classified

FDA source

Medtronic Vascular, Inc. began a recall of Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal... on 2021-06-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2136-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-07
Posted: 2021-07-23
Recalling firm: Medtronic, Inc.
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.
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
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.
FDA root cause: Under Investigation by firm
Action: On 06/07/2021, the firm initiated a verbal notification regarding an "URGENT MEDICAL DEVICE RECALL" which informed customers that Earlier this week, Medtronic identified the potential for a specific subset of 20Fr Endurant II/IIs Stent Graft Systems to have the potential for the Radiopaque Marker to detach during deployment. There is evidence that devices that used one batch of graft cover subassemblies has a higher potential to exhibit this failure mode. This is an acute failure of the delivery system, there are no concerns with previously implanted stent grafts. We are requesting that you immediately refrain from using this specific subset of products and place it in quarantine until further notice. You will be receiving an official recall notice with instructions for product return for credit or replacement. Your Sales Representative will assist you with this process. We apologize for the inconvenience; however, this action is necessary to ensure the utmost patient safety with the use of our products. On 06/18/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS 2-Day delivery that restated the verbal notification. The Customer Notification Letter instructed customers to: 1)Return all unused affected devices via their sales representative or calling customer service at 1-888-283-7868 or email [email protected]. 2)Complete the enclosed Customer Confirmation Form and email to [email protected]. 3)Forward this notice to all those who need to be aware within their organization. For questions or assistance, contact Customer Service at 1-888-283-7868.
Quantity in commerce: 21 devices
Distribution: 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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2136-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2135-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-04	2021-07-23
Z-2136-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-04	2021-07-23

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)