Zenith Alpha G38178Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002381787), received between Jul 25, 2019 and Feb 7, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Auto Stop” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2022Off-Label Use; Failure to Auto Stop; Off-Label Use; Failure to Auto Stop

  ACCORDING TO INITIAL REPORTER: A (B)(6) MALE PATIENT UNDERWENT A TVAR TYPE B DISSECTION PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS, G38178, WAS USED. THE TRIGGER WIRE WOULD NOT RELEASE FROM THE CANNULA. PHYSICIAN TOOK THE BACK HANDLE OFF AND PULLED THE TRIGGER WIRES OFF EXTERNALLY. THE GRAFT DEPLOYED SUCCESSFULLY. IT WAS NOTED THAT IT TOOK A LOT OF FORCE TO PULL BACK ON THE HANDLE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13469332 ↗
• MalfunctionJan 14, 2022Failure to Auto Stop; No Apparent Adverse Event; Failure to Auto Stop; No Apparent Adverse Event

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A TEVAR WAS COMPLETED (B)(6) 2022 IN WHICH THE ALPHA DEVICE HANDLE MADE NO CLICKING NOISE NOR DID IT COME TO A COMPLETE STOP INDICATING FULL DEPLOYMENT. IT WAS NOTED ON FLOURO IT APPEARED TO HAVE DEPLOYED. WE THEN MAGNIFIED THE VIEW DURING SLOW REMOVAL OF THE DILATOR AND CANNULA. THERE WAS NO ISSUE IN THE REMOVAL, BUT IT CAUSED CONCERN OF THE PHYSICIAN. 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 13256970 ↗
• MalfunctionJul 25, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

  ADDITIONAL INFORMATION RECEIVED FROM REP ON 05AUG2019: THERE WERE NO DIFFICULTIES IN REMOVING THE DELIVERY SYSTEM. WE DID OBSERVE THE SHAPE OF THE PROXIMAL ALPHA IMMEDIATELY AND USED A CODA TO OPEN IT. AFTER INFLATING A SECOND TIME THE PROXIMAL GRAFT ¿POPPED¿ OPEN AND HAD GOOD APPOSITION THEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8825898 ↗

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