Zenith Alpha G35400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002354002), received between Oct 20, 2016 and Oct 20, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• MalfunctionOct 20, 2016Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Remove; Activation, Positioning or Separation Problem

  DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: DURING THE TEVAR PROCEDURE, THE PHYSICIAN ATTEMPTED TO LAND THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT AT THE LEFT COMMON CAROTID ARTERY. AS THE DEVICE STARTED TO DEPLOY IT JUMPED BACK 4.5 CM ((B)(4)). THE REST OF THE DEVICE DEPLOYED IN THE NORMAL MANOR AND RELEASED FROM THE DELIVERY SYSTEM WITH NO PROBLEMS. DUE TO THE 4.5 CM GAP BETWEEN THE INTENDED LANDING ZONE AND THE ACTUAL LANDING ZONE, A ZTA-P-46-125-W GRAFT WAS SUCCESSFULLY PLACED LANDING WITH THE PROXIMAL GRAFT EDGE AT THE OSTIUM OF THE LEFT COMMON CAROTID ARTERY. AT THIS TIME A ZTA-D-42-204-W DEVICE WAS UTILIZED AND WENT THROUGH THE DEPLOYMENT DEVICE SEQUENCE IN THE PROPER ORDER. HOWEVER, THE DISTAL BARE STENT APPEARED TO BE STUCK IN THE BOTTOM CAP OF THE DELIVERY SYSTEM. THE HANDLE WAS DISMANTLED AND THE PHYSICIAN PULLED OFF ALL THE TRIGGER WIRES . THE PHYSICIAN PULLED THE GREY POSITIONER DOWN TO THE BOTTOM OF THE DEVICE TOUCHING THE BOTTOM OF THE STENT GRAFT BUT THE REVERSE TAPERED DILATOR TIP OF THE STENT GRAFT BARE METAL STENT AND COULD NOT BE REMOVED. IT WAS THEN NOTED THAT THE BARE STENT MUST HAVE CROSSED ON ITSELF AT THE STENT APICES ((B)(4)). AT THIS POINT A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6042809 ↗

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