Zenith Alpha G38173Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002381732), received between May 9, 2022 and May 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Auto Stop” (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.

• MalfunctionMay 9, 2022Failure to Auto Stop; Mechanical Jam; Failure to Auto Stop; Mechanical Jam

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A MALE PATIENT OF UNSPECIFIED AGE UNDERWENT AN TEVAR PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS, G38173, WAS USED. WHEN DEPLOYING THE HANDLE WIRES WERE PULLED BACK BUT NO WIRES CAME OUT. THE BLUE ROTATING HANDLE WAS JUST ROTATING. THE PHYSICIAN POPPED OFF THE TABS AND WAS ABLE TO MANUALLY DEPLOY THE GRAFT. 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 14336987 ↗

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