Zenith Alpha G35361Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002353616), received between Mar 19, 2020 and Apr 2, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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.

• InjuryApr 2, 2020Failure to Unfold or Unwrap; Appropriate Device Problem Term/Code Not Available; Failure to Unfold or Unwrap; Appropriate Device Problem Term/Code Not Available

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE ALPHA WAS ADVANCED INTO POSITION, OVERLAPPING A PREVIOUSLY IMPLANTED ALPHA THORACIC GRAFT, WHEN DEPLOYED AND TRIGGER WIRES REMOVED, THE MOST PROXIMAL STENT WAS NOT FULLY EXPANDED, THE APPEARANCE WAS AS THOUGH IT WAS BEING CONSTRAINED. A CODA BALLOON WAS THEN ADVANCED OVER THE LUNDERQUIST WIRE AND INFLATED HOWEVER BURST UPON INFLATION. A 26X40 ATLAS BALLOON WAS THEN INFLATED NUMEROUS TIMES BUT THE MOST PROXIMAL STENT REMAINED PERPENDICULAR TO THE OTHERS. AFTER A STERNOTOMY WAS PERFORMED AND THE ENDOGRAFT TAKEN OUT, PHYSICIAN COMMENTED THAT IT WAS NOT THE DELIVERY SYSTEM OR THE ENDOGRAFT ITSELF THAT CAUSED THE PROBLEM, IT WAS A COMBINATION OF THE ARTERIAL ANATOMY (ANGLE AND LUMEN SIZE) AND THE INDWELLING ENDOGRAFT THAT CAUSED THE STENT STRUT TO GET TRAPPED. PATIENT OUTCOME: THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. STERNOTOMY FOLLOWED BY REMOVAL OF ENDOGRAFT. ACCORDING TO INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DO TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 9916616 ↗
• InjuryMar 19, 2020Off-Label Use; Failure to Unfold or Unwrap; Device Tipped Over; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Failure to Unfold or Unwrap; Device Tipped Over; Appropriate Device Problem Term/Code Not Available

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 9852158 ↗

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