Zenith Alpha G38220Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002382203), received between Jan 24, 2020 and Jan 27, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

• InjuryJan 27, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT WAS SUPPOSED TO RETURN FOR ANOTHER AORTIC INTERVENTION AND POSSIBLE ATTEMPT TO REPAIR THE INFOLDING . THE PATIENT IS SAYING THE PAIN IS GONE AND NOT RETURNING FOR FOLLOW UP. APPEARED THAT THE BARE STENT RELEASED JUST PRIOR TO THE PRO FORM SUTURE AND THE GRAFT TIPPED TOWARDS THE LESSER CURVE OF THE ARCH.

  Patient problems: No Information

  MAUDE report 9631357 ↗
• InjuryJan 24, 2020Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED 14FEB2020: THE PATIENT WAS SUPPOSED TO RETURN FOR ANOTHER AORTIC INTERVENTION AND POSSIBLE ATTEMPT TO REPAIR THE INFOLDING . THE PATIENT IS SAYING THE PAIN IS GONE AND NOT RETURNING FOR FOLLOW UP. APPEARED THAT THE BARE STENT RELEASED JUST PRIOR TO THE PRO FORM SUTURE AND THE GRAFT TIPPED TOWARDS THE LESSER CURVE OF THE ARCH.

  Patient problems: No Information

  MAUDE report 9625670 ↗

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