Zenith Alpha G38179Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002381794), received between Nov 19, 2020 and Feb 21, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionFeb 21, 2022Off-Label Use; Failure to Auto Stop; Mechanical Jam; Off-Label Use; Failure to Auto Stop; Mechanical Jam

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT UNDERWENT A TVAR IN A TYPE B DISSECTION PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS, G38179, WAS USED. THE TRIGGER WIRE WOULD NOT RELEASE FROM THE CANNULA. THE PHYSICIAN PUSHED THE SHEATH UP IN PLACE AND TOOK THE HANDLE OFF AND PULLED THE TRIGGER WIRE OFF EXTERNALLY. THE GRAFT DEPLOYED SUCCESSFULLY. IT WAS NOTED THAT IT TOOK A LOT OF FORCE TO PULL BACK ON THE HANDLE. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13567529 ↗
• MalfunctionNov 19, 2020Difficult to Advance; Difficult to Advance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10866290 ↗

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