Zenith Alpha G35401Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002354019), received between Mar 2, 2017 and Mar 2, 2017 — 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.

• MalfunctionMar 2, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: GRAFT WAS DEPLOYED AND THE USER REMOVED THE 1ST TRIGGER WIRE (GREEN HANDLE). UPON DEPLOYING THE BARE STENT, THE USER ATTEMPTED TO REMOVE GRAY THUMB SCREW, HAVING TO USE FORCEPS TO LOOSEN. AT THIS TIME THE USER STILL COULD NOT USE THE BLACK SLIDE BAR. TO REMEDY THIS THE DM INSTRUCTED THE PHYSICIAN TO BREAK BACK OFF GREEN HANDLE, WHICH LOOSENED THE SLIDE BAR. THE PROCEDURE WAS ABLE TO BE COMPLETED AND WAS OVERALL SUCCESSFUL. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6371141 ↗

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