Zenith Alpha G35523Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002355238), received between Oct 19, 2021 and Oct 26, 2021 — classified as 2 injuries.

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

• InjuryOct 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: COMPONENT SEPARATION. ON (B)(6) 2020: ENDOVASCULAR REPAIR OF RUPTURED AAA WITH ENDOVASCULAR GRAFTS; (B)(6) 2020: TYPE III ENDOLEAK REPAIR OF 2 AORTIC CUFFS. NO DETAILED INFORMATION IS AVAILABLE AS THESE PROCEDURES WERE PERFORMED AT OUTSIDE FACILITY. PATIENT OUTCOME: NO INFORMATION REGARDING THE PATIENT HAS BEEN RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12697978 ↗
• InjuryOct 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED 27OCT2021: RECEIVED THE CT SCAN. THE PHYSICIAN REVIEWED THE IMAGES AND IT APPEARS THAT THE COMPONENT SEPARATION WAS BETWEEN THE CMD AND BIFURCATED DEVICE. ALPHA PORTION LOOKED INTACT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12653538 ↗

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