Zenith Alpha G35337Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002353371), received between Feb 4, 2019 and May 25, 2022 — classified as 3 deaths.

The most frequently reported specific device problem is “Packaging Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathMay 25, 2022Packaging Problem; Packaging Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: EMAIL 28APR2022: THE PHYSICIAN DEPLOYED THE DEVICE IN THE THORACIC AORTA JUST DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE DEVICE DEPLOYED NORMALLY AND HAD NO TECHNICAL ISSUES. THE GRAFT LANDED SLIGHTLY DISTAL TO WHERE THEY WANTED TO LAND BUT WERE HAPPY WITH THE RESULT AFTER ANGIOGRAM. PATIENT CAME BACK TO HOSPITAL A WEEK AFTER RELEASE AND PASSED AWAY FROM INFECTION. AORTA AND GRAFT WERE INFECTED. SHE IS UNSURE AS TO WHY THIS HAPPENED AND WHAT CAUSED INFECTION. PATIENT OUTCOME: PATIENT PASSED AWAY.

  Patient problems: Unspecified Infection

  MAUDE report 14495506 ↗
• DeathMay 9, 2022Adverse Event Without Identified Device or Use Problem; Packaging Problem; Adverse Event Without Identified Device or Use Problem; Packaging Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: EMAIL 28APR2022: THE PHYSICIAN DEPLOYED THE DEVICE IN THE THORACIC AORTA JUST DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE DEVICE DEPLOYED NORMALLY AND HAD NO TECHNICAL ISSUES. THE GRAFT LANDED SLIGHTLY DISTAL TO WHERE THEY WANTED TO LAND BUT WERE HAPPY WITH THE RESULT AFTER ANGIOGRAM. PATIENT CAME BACK TO HOSPITAL A WEEK AFTER RELEASE AND PASSED AWAY FROM INFECTION. AORTA AND GRAFT WERE INFECTED. SHE IS UNSURE AS TO WHY THIS HAPPENED AND WHAT CAUSED INFECTION. PATIENT OUTCOME: PATIENT PASSED AWAY.

  Patient problems: Unspecified Infection

  MAUDE report 14336931 ↗
• DeathFeb 4, 2019Malposition of Device; Migration; Malposition of Device; Migration

  ADDITIONAL INFORMATION RECEIVED ON 06FEB2019: IT WAS A BIT OF A UNIQUE CASE, BUT WAS FUNDAMENTALLY AN ABDOMINAL CASE WITH A VERY LONG DISTANCE FROM RENAL TO BIFURCATION AND STEEP ANGULATION. THE PHYSICIANS THOUGHT IT WOULD ALLOW THEM TO GET THE CONTRALATERAL LIMB LOWER TO THE BIFURCATION TO EASE CANNULATION IN A MUCH MORE CONFINED LUMEN. THE VESSEL WAS 23-24MM MEASURED ADVENTITIA TO ADVENTITIA.

  Patient problems: Death

  MAUDE report 8300999 ↗

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