Zenith Alpha G35391Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002353913), received between Aug 1, 2018 and Jun 13, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2022Improper or Incorrect Procedure or Method; Difficult to Open or Close; Activation Failure; Improper or Incorrect Procedure or Method; Difficult to Open or Close; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT WITH PREVIOUS REPAIR HAD A GRAFT (UNKNOWN MANUFACTURER) 12 MONTHS AGO. AN ENDOLEAK WAS NOTED 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. THE PROCEDURE WAS COMPLETED USING A G35351-ZTA-P-34-161-W, E4239129. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14673529 ↗
• MalfunctionAug 1, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ¿NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7738061 ↗

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