Zenith Alpha G38075Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002380759), received between Feb 18, 2021 and Nov 12, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2021Off-Label Use; Difficult to Remove; Device Damaged Prior to Use; Migration; Off-Label Use; Difficult to Remove; Device Damaged Prior to Use; Migration

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: UPON DEPLOYMENT OF THE MODIFIED GRAFT, THE DELIVERY SYSTEM WAS IN THE PROCESS OF BEING REMOVED WHEN IT SEEMED TO GET CAUGHT UP ON THE GRAFT AS IT WAS BEING REMOVED. IT WAS THEN NOTICED THAT THE GRAFT SEEMED TO HAVE MOVED DISTAL TO WHERE IT WAS RELEASED CAUSING A SHIFT FROM WHERE IT WAS ORIGINALLY AT. THE CELIAC ARTERY WAS THEN UNABLE TO BE CANNULATED. IT WAS NOTED AFTER FINALLY REMOVING THE DELIVERY SYSTEM THAT ONE OF THE TRIGGER WIRES WAS STILL ABLE TO BE SEEN ON THE SYSTEM WHERE IT SHOULD HAVE BEEN ROTATED INTO THE HANDLE. 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 12804386 ↗
• InjuryNov 2, 2021Off-Label Use; Difficult to Remove; Device Damaged Prior to Use; Migration; Off-Label Use; Difficult to Remove; Device Damaged Prior to Use; Migration

  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

  MAUDE report 12735553 ↗
• MalfunctionFeb 18, 2021Off-Label Use; Material Separation; Off-Label Use; Material Separation

  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 11341583 ↗

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