Zenith Alpha G35376Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002353760), received between Mar 15, 2017 and Mar 15, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult To Position” (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.

• InjuryMar 15, 2017Leak/Splash; Difficult To Position; Leak/Splash; Difficult To Position

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "THE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT WAS IMPLANTED ON (B)(6) 2017. THE DISTRICT MANAGER NOTED THAT THE BOTTOM EDGE OF THE STENT CAUGHT ON THE DELIVERY SYSTEM¿S PREFORM CAUSING THE BOTTOM EDGE OF THE STENT TO MOVE BACK APPROXIMATELY 1CM FROM THE LANDING ZONE. NO ENDOLEAK WAS NOTED AT THAT TIME AND THE DR. INDICATED THERE WAS NO FAILURE WITH THE PROCEDURE. NOW A TYPE 1A ENDOLEAK HAS BEEN NOTED." PATIENT OUTCOME: NO PATIENT INFORMATION AVAILABLE, FUTURE PROCEDURES ARE PENDING.

  Patient problems: No Code Available

  MAUDE report 6405310 ↗

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