Zenith Alpha G38208Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002382081), received between Dec 20, 2016 and Dec 20, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionDec 20, 2016Difficult to Advance; Difficult to Advance

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "THERE WAS DIFFICULTY TRACKING THE DEVICE DUE TO TORTUOSITY. BECAUSE OF THE TORTUOSITY, IT APPEARS THE DILATOR STRETCHED THE TIP OF THE SHEATH. WE TOOK THE DEVICE OUT TO SWITCH OUT FOR A DOUBLE CURVED LUNDERQUIST. WHEN TRYING TO RE-ADVANCE THE DEVICE, WE NOTICED THAT THE TIP OF THE SHEATH WAS STRETCHED OUT PREVENTING US TO CONTINUE TO ADVANCE THROUGH THE ILIAC SYSTEM. WE REMOVED THE DEVICE AND PUT IN A 24FR. CHEK-FLO SHEATH INTO THE DISTAL ABDOMINAL AORTA. THE ALPHA DEVICE/SHEATH WAS ADVANCED OVER THE WIRE, THROUGH THE 24FR SHEATH INTO PROPER POSITION. IT WAS DEPLOYED WITHOUT ANY DIFFICULTY." PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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 6188346 ↗

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