Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF36...

FDA Device Recall #Z-2136-2021 — Class II — June 7, 2021

Recall Summary

Recall Number Z-2136-2021
Classification Class II — Moderate risk
Date Initiated June 7, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medtronic Vascular, Inc.
Location Santa Rosa, CA
Product Type Devices
Quantity 21 devices

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.

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.

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.

Lot / 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;

Other Recalls from Medtronic Vascular, Inc.

Recall # Classification Product Date
Z-1042-2022 Class II Medtronic IN.PACT Admiral, Paclitaxel-coated PT... Mar 23, 2022
Z-1043-2022 Class II Medtronic IN.PACT AV, Paclitaxel-coated PTA Bal... Mar 23, 2022
Z-0657-2022 Class II Endurant, Endurant II and Endurant IIs Stent Gr... Dec 21, 2021
Z-0290-2022 Class II Endurant Stent Graft System REF/Description: ... Oct 15, 2021
Z-0291-2022 Class II Endurant II Stent Graft System REF/Description:... Oct 15, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.