Zenith Alpha G35360Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002353609), received between Jun 25, 2018 and Jun 25, 2018 — classified as 1 death.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P140016); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathJun 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "PATIENT DIED, CAUSE OF DEATH UNKNOWN." ADDITIONAL INFORMATION RECEIVED 12JUN2018: "PATIENT EXPIRED ON (B)(6) 2018." "PATIENT EXPERIENCED SPINAL SHOCK FROM PARAPLEGIA, BUT THIS WAS NOT DEVICE-SPECIFIC OR RELATED. THE PHYSICIAN ASSERTS THAT THE PROCEDURE RESULTED IN THE PARAPLEGIA COMPLICATION, AND THAT IT WAS NOT DEVICE SPECIFIC OR RELATED." "PRODUCT INFORMATION: A) (B)(6) 2011 INDEX TEVAR: ZTEG-2D-34-186-PF-US, LOT E2463077----AND ZTEG-2P-38-202-PF-US, LOT E2776443. B) (B)(6) 2014 TEVAR (PROXIMAL EXTENSION FOR DISEASE PROGRESSION) ZTEG-2P-38-127-PF-US, LOT E3078098" PATIENT OUTCOME: PATIENT IS DECEASED

  Patient problems: Death; Paraplegia

  MAUDE report 7633028 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140016. One submission often covers many models, so check the product and lot details in each record.

• Z-0043-2026 · Sep 18, 2025 · Open, Classified
  Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W
• Z-2099-2017 · Mar 22, 2017 · Terminated
  Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descend