Endurant — Class II medical device recall Z-0657-2022

Ongoing recall by Medtronic Vascular, Inc., reported 2022-03-02, distributed nationwide. Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip t

Recall number	`Z-0657-2022`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Medtronic Vascular, Inc., Santa Rosa, CA, United States
Recall initiated	2021-12-21
Classified	2022-02-18
Reported by FDA	2022-03-02
Distributed	Nationwide (US)
Countries outside the US	AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IT, JO, JP, KE, KR, KW, KY, LB, LT, LU, LV, MA, MT, MX, MY, NL, NO, NZ, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UA, UY, VN, ZA
Quantity	14,629 devices
Reason classes	device malfunction
UPC / GTIN / UDI-DI	`00613994990969`, `00613994990976`, `00613994990983`, `00613994991027`, `00613994991034`, `00613994991041`, `00613994991133`, `00613994991164`, `00613994991195`, `00613994991201`, `00613994991218`, `00613994991225`, `00613994991249`, `00613994991263`, `00613994991270`, `00613994991294`, `00613994991300`, `00613994991324`, `00613994991423`, `00613994991430`, `00613994991447`, `00613994991454`, `00613994991461`, `00613994991478`, `00613994991485` and 135 more
Serial numbers	`00613994990969`, `00613994990976`, `00613994990983`, `00613994991027`, `00613994991034`, `00613994991041`, `00613994991133`, `00613994991164`, `00613994991195`, `00613994991201`, `00613994991218`, `00613994991225`, `00613994991249`, `00613994991263`, `00613994991270`, `00613994991294`, `00613994991300`, `00613994991324`, `00613994991423`, `00613994991430`, `00613994991447`, `00613994991454`, `00613994991461`, `00613994991478`, `00613994991485` and 475 more
Model numbers	`ENBF2313C120EE`, `ESBF2314C103E`, `ETBF2313C124E`

Product

Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF2316C145EE; ENBF2316C170EE; ENBF2513C120EE; ENBF2513C145EE; ENBF2513C170EE; ENBF2516C120EE; ENBF2516C145EE; ENBF2516C170EE; ENBF2813C145EE; ENBF2813C170EE; ENBF2816C120EE; ENBF2816C145EE; ENBF2816C170EE; ENBF3216C120EE; ENBF3216C145EE; ENBF3216C170EE; ENBF3616C145EE; ENBF3616C170EE; ENCF2323C45EE; ENCF2525C45EE; ENCF2828C45EE; ENCF3232C45EE; ENCF3636C45EE; ENTF2323C70EE; ENTF2525C70EE; ENTF2828C70EE; Medtronic Endurant II Stent Graft System Model/REF ETBF2313C124E; ETBF2313C124EE; ETBF2313C145EE; ETBF2313C145EJ; ETBF2313C166EE; ETBF2313C166EJ; ETBF2316C124E; ETBF2316C124EE; ETBF2316C124EJ; ETBF2316C145E; ETBF2316C145EE; ETBF2316C145EJ; ETBF2316C166E; ETBF2316C166EE; ETBF2316C166EJ; ETBF2513C124E; ETBF2513C124EE; ETBF2513C124EJ; ETBF2513C145EE; ETBF2513C145EJ; ETBF2513C166E; ETBF2513C166EE; ETBF2513C166EJ; ETBF2516C124EE; ETBF2516C145E; ETBF2516C145EE; ETBF2516C145EJ; ETBF2516C166E; ETBF2516C166EE; ETBF2516C166EJ; ETBF2813C124EE; ETBF2813C124EJ; ETBF2813C145E; ETBF2813C145EE; ETBF2813C145EJ; ETBF2813C166E; ETBF2813C166EE; ETBF2813C166EJ; ETBF2816C124EE; ETBF2816C124EJ; ETBF2816C145E; ETBF2816C145EE; ETBF2816C145EJ; ETBF2816C166E; ETBF2816C166EE; ETBF2816C166EJ; ETBF2820C124EE; ETBF2820C145EE; ETBF2820C145EJ; ETBF2820C166E; ETBF2820C166EE; ETBF2820C166EJ; ETBF3216C124E; ETBF3216C124EE; ETBF3216C124EJ; ETBF3216C145E; ETBF3216C145EE; ETBF3216C145EJ; ETBF3216C166EE; ETBF3216C166EJ; ETBF3220C124EE; ETBF3220C145EE; ETBF3220C166E; ETBF3220C166EE; ETBF3220C166EJ; ETBF3616C145E; ETBF3616C145EE; ETBF3616C145EJ; ETBF3616C166E; ETBF3616C166EE; ETBF3616C166EJ; ETBF3620C145EE; ETBF3620C166EE; ETBF3620C166EJ; ETCF2323C49E; ETCF2323C49EE; ETCF2525C49E; ETCF2525C49EE; ETCF2525C49EJ; ETCF2828C49E; ETCF2828C49EE; ETCF2828C49EJ; ETCF3232C49E; ETCF3232C49EE; ETCF3232C49EJ; ETCF3636C49E; ETCF3636C49EE; ETCF3636C49EJ; ETTF2323C70E; ETTF2323C70EE; ETTF2323C70EJ; ETTF2525C70E; ETTF2525C70EE; ETTF2525C70EJ; ETTF2828C70E; ETTF2828C70EE; ETTF2828C70EJ; ETTF3232C70E; ETTF3232C70EE; ETTF3232C70EJ; ETTF3636C70E; ETTF3636C70EE; ETTF3636C70EJ; ETUF2314C102E; ETUF2314C102EE; ETUF2314C102EJ; ETUF2514C102E; ETUF2514C102EE; ETUF2514C102EJ; ETUF2814C102E; ETUF2814C102EE; ETUF2814C102EJ; ETUF3214C102E; ETUF3214C102EE; ETUF3614C102E; ETUF3614C102EE; Medtronic Endurant IIs Stent Graft System Model/REF: ESBF2314C103E; ESBF2314C103EE; ESBF2314C103EJ; ESBF2514C103E; ESBF2514C103EE; ESBF2514C103EJ; ESBF2814C103E; ESBF2814C103EE; ESBF2814C103EJ; ESBF3214C103E; ESBF3214C103EE; ESBF3214C103EJ; ESBF3614C103E; ESBF3614C103EE; ESBF3614C103EJ; Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

Reason for recall

Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0657-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.