Zenith Alpha G38172Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002381725), received between Jun 24, 2016 and Aug 5, 2021 — classified as 1 death, 2 malfunctions.

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

• MalfunctionAug 5, 2021Mechanical Jam; Mechanical Jam

  ACCORDING TO INITIAL REPORTER. THE TRIGGER WIRES DID NOT RELEASE UPON TURNING THE HANDLE ((B)(4)). THEY DISASSEMBLED THE HANDLE TO MANUALLY RELEASE THE TRIGGER WIRES AND THE TRIGGER WIRES DID RELEASE ENABLING THE GRAFT TO DEPLOY. THEN, UPON REMOVING THE DELIVERY SYSTEM, THE DILATOR TIP SEPARATED ((B)(4)). IT WAS ALREADY ENOUGH OUT OF THE PATIENT THAT THEY WERE ABLE TO MANUALLY REMOVE THE DILATOR TIP. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280278 ↗
• MalfunctionAug 5, 2021Loss of or Failure to Bond; Off-Label Use; Loss of or Failure to Bond; Off-Label Use

  ACCORDING TO INITIAL REPORT THE TRIGGER WIRES DID NOT RELEASE UPON TURNING THE HANDLE ((B)(4)). THEY DISASSEMBLED THE HANDLE TO MANUALLY RELEASE THE TRIGGER WIRES AND THE TRIGGER WIRES DID RELEASE ENABLING THE GRAFT TO DEPLOY. THEN, UPON REMOVING THE DELIVERY SYSTEM, THE DILATOR TIP SEPARATED ((B)(4)). IT WAS ALREADY ENOUGH OUT OF THE PATIENT THAT THEY WERE ABLE TO MANUALLY REMOVE THE DILATOR TIP. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280241 ↗
• DeathJun 24, 2016Material Erosion; Migration or Expulsion of Device; Migration or Expulsion of Device

  DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: MY PATIENT WHO UNDERWENT AN ENDOVASCULAR ARCH BRANCH REPAIR CAME BACK TO THE HOSPITAL YESTERDAY WITH EVIDENCE OF GI BLEEDING. ON CT, HER ANEURYSM REMAINS EXCLUDED. HOWEVER, ON ENDOSCOPY EVALUATION TODAY, SHE WAS FOUND TO HAVE A TRACHEA-ESOPHAGEAL FISTULA WITH GRAFT MATERIAL VISUALIZED ON HER ENDOSCOPY. ADDITIONAL INFORMATION PROVIDED. DURING OUR CONVERSATION WITH THE SURGEON HE PROVIDED THE FOLLOWING: THE EROSION IS NOT LOCATED NEAR THE SEAL ZONE; THE ALPHA GRAFT IS IN THE AREA OF THE EROSION; APPROXIMATELY 1/3 OF THE ALPHA GRAFT IS INVOLVED IN THE ERODED AREA; THE GRAFT SITS IN THE ESOPHAGUS; NO ISSUES WITH OVERSIZING; THE PATIENT HAD BACTEREMIA SOMETIME FOLLOWING THE GRAFT IMPLANT (MONTHS AGO) AND RESPONDED TO TREATMENT. PATIENT OUTCOME: SHE IS NOT ACTIVELY BLEEDING NOW AND DOES NOT HAVE ANY SIGNS OF SYSTEMIC INFECTION ALTHOUGH THERE IS SOME AIR AROUND THE GRAFT ON CT AT THE AREA OF THE FISTULA. SHE IS NOT A CANDIDATE FOR ANY SURGICAL TREATMENT AND WILL BE TREATED WITH LIFELONG SUPPRESSIVE ANTIBIOTICS.

  Patient problems: Bacterial Infection; Death; Erosion; Fistula; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 5747558 ↗

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