Zenith Alpha G35353Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002353531), received between Jun 7, 2024 and Jun 7, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2024Off-Label Use; Off-Label Use

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE ATTACHED DEVICE WAS USED IN A CASE TODAY. HAD PATIENT CONTACT. WAS ABLE TO REMOVED IT SUCCESSFULLY AND NO HARM CAUSED TO PATIENT. THE DOCTOR WAS SPINNING THE BLUE HANDLE AND THE TRIGGER WIRES WERE DISASSOCIATED WITH THE DEVICE. WE HAD TO BREAK BACK HANDLE AND MANUALLY RELEASE THE TRIGGER WIRES. ADDITIONAL INFORMATION RECEIVED 07FEB2024: WAS THE GRAFT ALTERED IN ANY WAY PRIOR TO IMPLANT? YES ADDITIONAL INFORMATION RECEIVED 07FEB2024: IT IS NOTED THAT ¿THE DOCTOR WAS SPINNING THE BLUE HANDLE AND THE TRIGGER WIRES WERE DISASSOCIATED WITH THE DEVICE¿. DOES THIS MEAN THAT IT WAS NOT POSSIBLE TO ROTATE THE HANDLE TO STOP AND THEREFORE KEPT TURNING? CORRECT IN THE PHYSICIAN¿S OPINION, WERE THE TRIGGER WIRES DISASSOCIATED PRIOR TO SPINNING THE BLUE HANDLE OR DID IT OCCUR DURING THE ROTATION? BEFORE WAS RELEASE TROUBLESHOOTING UTILIZED AS PER THE IFU? YES WAS THE PHYSICIAN ABLE TO LAND THE DEVICE IN THE PLANNED TARGET ZONE? YES PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482794 ↗

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