Zenith Alpha G35356Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002353562), received between Sep 9, 2016 and Apr 2, 2024 — classified as 2 malfunctions.

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

• MalfunctionApr 2, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "UPON DEPLOYMENT OF THE DEVICE, IT WAS MOVING BACKWARDS AND THEN UPON SURGEON MANIPULATING IT JUMPED FORWARD AND ENCROACHED ON THE ARCH VESSELS (INNOMINATE & LEFT COMMON CAROTID ARTERY)LCCA)). THE LEFT SUBCLAVIAN ARTERY (LSA) WAS PLANNED FOR COVERAGE AS A LCCA-LSA BYPASS WAS DONE PRIOR. UPON AN ANGIO THE LCCA HAD A FAIR AMOUNT OF COVERAGE THAT REQUIRED STENTING TO ENSURE THE VESSEL REMAINS OPEN. FINAL RESULT OF THE CASE WAS AS PLANNED WITH NO ENDOLEAK AND ALL VESSELS PRESERVED. NO PREEXISTING CONDITIONS OR COMORBIDITIES PRESENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018944 ↗
• MalfunctionSep 9, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING DEPLOYMENT, THERE WAS A LOT OF DIFFICULTY RETRACTING THE SHEATH. ONCE THE SHEATH GOT TO THE FIRST PART OF THE BARE STENT, THERE WAS EXTREME DIFFICULTY RETRACTING THE SHEATH ANY MORE. THEY HEARD A SNAP. THEY BELIEVE THAT THE SHEATH'S NITINOL CORE BROKE. BECAUSE THE SHEATH WOULD NOT RETRACT FROM THAT POINT ON, THERE WAS FEAR TO TRY TO COMPLETE DEPLOYMENT ANY FURTHER. IT WAS DECIDED TO REMOVE THE DELIVERY SYSTEM AND REPLACE WITH A NEW GRAFT. THEY COMPLETED THE PROCEDURE SUCCESSFULLY WITH A SHORTER GRAFT (36 X 161). THE PHYSICIAN AND REP SUSPECT THAT THE TIGHT AORTIC ARCH MADE DEPLOYMENT DIFFICULT. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5938700 ↗

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