Zenith Alpha G38191Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002381916), received between Jun 9, 2021 and Mar 14, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2024Mechanical Jam; Mechanical Jam

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE ATTACHED GRAFT HAD ISSUES WITH DEPLOYMENT. WE MOST DEPLOYED THIS GRAFT FIRST AND THE HANDLE DID NOT CLICK WHEN TURNING (HAN SAID THE HANDLE WAS DISASSOCIATED). SO HE HAD TO POP THE BACK OF THE HANDLE OFF AND PULL THE TRIGGER WIRES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18901617 ↗
• MalfunctionJun 13, 2022Mechanical Jam; Difficult or Delayed Separation; Mechanical Jam; Difficult or Delayed Separation

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A 74 YEAR OLD FEMALE PATIENT UNDERWENT A TVAR PROCEDURE IN WHICH THE ZENITH ALPHA THROACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS, G38191, WAS USED. THE PROFORM WIRE DID NOT DETACH FROM IMPLANT. THE DISTRICT MANAGER AND SURGEON BROKE APART THE HANDLE TO MANUALLY RELEASE THE WIRE AND GRAFT. THE GRAFT HAD PULLED BACK FROM INTENDED SPOT OF DEPLOYMENT AS THE PHYSICIAN HAD THOUGHT THE GRAFT HAD DETACHED FROM THE DELIVERY SYSTEM. AT THIS TIME THERE IS NO FOLLOW UP PROCEDURE BEING SCHEDULED TO PLACE A GRAFT IN THE AREA ABOVE THE IMPLANTED GRAFT, HOWEVER, THE SURGEON STATED AT SOME POINT IN THE FUTURE ANOTHER PROCEDURE WILL NEED TO BE DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674165 ↗
• MalfunctionJun 9, 2021Failure to Advance; Failure to Advance

  ACCORDING TO INITIAL REPORTER: I DID A CASE WITH A PHYSICIAN AND OUR ALPHA THORACIC DEVICE WOULD NOT TRACK DUE TO THE LENGTH OF THE NOSE CONE BEING PROBLEMATIC, SPECIFICALLY IN THIS PATIENT¿S ANATOMY. IT WAS THE 2ND DEVICE THAT WOULDN¿T TRACK. ADDITIONAL INFORMATION RECEIVED ON 01JUN2021: LANDED AN ALPHA GRAFT AT THE LEFT SUBCLAVIAN ARTERY. THIS 2ND PIECE WOULD NOT TRACK THROUGH THE FIRST GRAFT DUE TO THE NOSE CONE LENGTH COMBINED WITH THE PATIENT'S TORTUOUS ANATOMY. ADDITIONAL INFORMATION RECEIVED ON 02JUN2021: THE FIRST DEVICE MENTIONED IN THE INITIAL E-MAIL WAS THE OTHER DEVICE INVOLVED IN THIS PROCEDURE, AND IT HAD NO PROBLEM. TO CLARIFY, ONLY THE SECOND DEVICE DID NOT TRACK. ADDITIONAL INFORMATION RECEIVED 03JUN2021: THE FIRST DEVICE WAS IMPLANTED WITH NO ISSUE AT THE LEFT SUBCLAVIAN ARTERY. THE 2ND DEVICE WOULD NOT TRACK THROUGH THE FIRST DEVICE DUE TO THE NOSE CONE IN COMBINATION WITH THE PATIENTS ANATOMY. THE ASCENDING AORTA WAS SHORT, THE ARCH WAS TIGHT AND THE FIRST STENT BEING IN PLACE TOOK AWAY THE ABILITY TO ADVANCE THE DEVICE. PATIENT HAD 2CM SEAL ZONE DISTAL TO THE LEFT SUBCLAVIAN ARTERY AND THEN A LARGE ANEURYSM IMMEDIATELY AFTER. PLAN WAS TO SEAL PROXIMALLY WITH A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964316 ↗

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