Zenith Alpha G38204Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002382043), received between May 1, 2017 and May 26, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• InjuryMay 26, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A REPAIR FOR A PATIENT WITH A THORACIC ANEURYSM WAS PERFORMED. THE CASE STARTED SMOOTHLY AND ACCESS WAS NOT AN ISSUE. AS THE DEVICE WAS INTRODUCED TO THE TABLE, THE CUSTOMER COMMENTED ON THE S-CURVES IN THE SHEATH DUE TO THE VERTICAL STORAGE OF THE DEVICE. THE DEVICE WAS ADVANCED ON THE WIRE AND POSITIONED FOR DEPLOYMENT. THE DEVICE WAS THEN FULLY DEPLOYED, MISSING THE IDEAL LANDING ZONE. THE DILATOR TIP AND SHEATH WERE RETRACTED OUT OF THE PATIENT WHERE THE CUSTOMER NOTED THE WHITE DILATOR SHOWED SIGN OF IMPERFECTION - ATTRIBUTING TO THE MALFUNCTION OF THE GRAFT PLACEMENT. PATIENT NOT COVID POSITIVE. WAS TIGHT ANGLED WHICH YOU SHOULD BE ABLE TO SEE ON CT. DEVICE WAS S SHAPED OUT OF PACKAGING AND I BROUGHT IT UP SEVERAL TIMES BECAUSE I WAS CONCERNED. IT WOULD NOT DEPLOY EASILY AND TOOK A LOT OF FORCE AND THE DEVICE WAS LIKE AN ACCORDION WHEN IT CAME OUT. PULLED BACK DUE TO DIFFICULTY IN DEPLOYMENT HAD TO PLACE ADDITIONAL GRAFT. HE HAD RETROGRADE DISSECTION WITH TAMPONADE. HAD TO GET EMERGENT ARCH REPAIR. STROKE, RESP FAILURE, RENAL FAILURE POSTOPERATIVE STILL IN HOUSE. PATIENT OUTCOME: THE CASE WAS CONTINUED, EXTENDING WITH AN ADD

  Patient problems: Vascular Dissection

  MAUDE report 11884312 ↗
• MalfunctionMay 1, 2017Detachment Of Device Component; Detachment Of Device Component

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: TOP PORTION OF THE HEMOSTATIC VALVE DETACHED AT THE END OF THE CASE. THERE WAS NO BLEEDING FROM THE HEMOSTATIC VALVE. THE DEVICE WAS ABLE TO BE REMOVED BY HAND; NO ADDITIONAL PROCEDURES WERE NEEDED. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6533242 ↗

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