Zenith Alpha G35373Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002353739), received between Mar 8, 2016 and Jun 21, 2021 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2021Mechanical Jam; Mechanical Jam

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12030818 ↗
• MalfunctionJan 3, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "DURING A TAA PROCEDURE THE PHYSICIAN HAD DIFFICULTY INITIATING THE UNSHEATHING OF THE DEVICE. AT THIS POINT THE PHYSICIAN DID NOT FEEL COMFORTABLE PROCEEDING WITH THE DEVICE AND IT WAS REMOVED. THE PROCEDURE WAS FINISHED WITH ANOTHER OF THE SAME DEVICE". PATIENT OUTCOME: THE PATIENT DIDN'T HAVE ANY ADVERSE EFFECTS DUE TO THIS OCCURENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6217605 ↗
• InjuryMar 8, 2016Activation, Positioning or Separation Problem

  DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: ALPHA ENDOGRAFT WAS DEPLOYED IN THE ARCH OF THE AORTA TO FIX AN ENDOLEAK OF A PREVIOUS GRAFT (46MM MEDTRONIC VALIANT). THE PROXIMAL STENT DEPLOYED A LITTLE TWISTED. WE WANTED TO BALLOON WITH A CODA 46 TO STRAIGHTEN OUT THE STENT AND MAKE SURE IT OPPOSES WELL TO THE AORTA. AORTA MEASURED 42MM. PLACED 46MM CODA AND INFLATED WITH A 60CC SYRINGE. CONTRAST VOLUME WAS ABOUT 1/3 POSSIBLY 1/2. WE INFLATED ALL THE WAY AND THE CODA WAS NOT FULLY OPPOSED TO THE ENDOGRAFT SO WE THOUGHT THAT 60CC WAS NOT ENOUGH TO INFLATE CODA TO 46MM. WE INFLATED ANOTHER 5-10CC AND THEN THE CODA POPPED. WE WERE ABLE TO BRING IT BACK INTO THE SHEATH AND NOTHING WAS DETACHED FROM IT. WE USED ANOTHER CODA 46 AND USED ABOUT 65CC TO INFLATE IT ALL THE WAY TO IRON OUT THE ALPHA GRAFT. HAD TO TROUBLESHOOT AND PULL OUT THE TRIGGER WIRES WITH PLIERS. PATIENT OUTCOME: EVENT LENGTHENED PROCEDURE TIME BY 40 MINUTES. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE AND 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 Code Available

  MAUDE report 5485387 ↗

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