Zenith Alpha G35339Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002353395), received between Oct 14, 2022 and Oct 14, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryOct 14, 2022Loss of or Failure to Bond; Patient Device Interaction Problem; Loss of or Failure to Bond; Patient Device Interaction Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT WITH PREVIOUS REPAIR HAD A GRAFT (UNKNOWN MANUFACTURER) 12 MONTHS AGO. AN ENDOLEAK WAS NOTED (B)(4) AND A G35391-ZTA-D-34-142-W WAS USED IN ATTEMPT TO REPAIR THE ENDOLEAK. FOUR, POSSIBLY FIVE STENTS APPEARED TO NOT OPEN. ALL BUT ONE WAS ABLE TO BE RESHEATHED; THE LAST STENT WAS ABLE TO BE REMOVED BY SLOWLY REMOVING THE WHOLE DELIVERY SYSTEM. ((B)(4)- FDA MFG REPORT# 3002808486-2022-00815) THE PROCEDURE WAS COMPLETED USING A G35351-ZTA-P-34-161-W, E4239129. INFORMATION CONCERNING THE UNKNOWN GRAFT (USED IN THE FIRST PROCEDURE, 12 MONTHS AGO): (B)(6) 2017: RIGHT TO LEFT CAROTID TO CAROTID BYPASS 7MM (DEVICE FROM ANOTHER MANUFACTURER), LEFT CAROTID TO SUBCLAVIAN ARTERY BYPASS 7MM (DEVICE FROM ANOTHER MANUFACTURER), TEVAR WITH 36-32MM AND 32MM COOK ALPHA STENT GRAFTS WITH INNOMINATE SNORKEL WITH 13MM STENT GRAFT (DEVICE FROM ANOTHER MANUFACTURER), STENT (DEVICE FROM ANOTHER MANUFACTURER) PLACEMENT IN THE DISTAL AORTIC ARCH. (B)(6) 2017: OPEN REPAIR OF AAA WITH AORTOBIILIAC GRAFT 22MM X 11MM WITH VISCERAL ARTERY DEBRANCHING WITH TWO 14MM X 7MM BIFURCATED GRAFTS OFF AORTOILIAC RECONSTRUCTION. (B)(6) 2017: REDO STENTING OF RIGHT

  Patient problems: Clinical Endoleak

  MAUDE report 15603169 ↗

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