Zenith Alpha G35344Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002353449), received between Mar 8, 2017 and Aug 18, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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. 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.

• MalfunctionAug 18, 2017Device Damaged by Another Device; Difficult to Advance; Device Damaged by Another Device; Difficult to Advance

  CLARIFICATION OF DESCRIPTION OF EVENT RECEIVED 22AUG2017: YES SOME OF THIS INFORMATION IS INCORRECT. THE SECOND DEVICE WAS NOT DELIVERED THROUGH THE SHEATH OF THE FIRST DEVICE, RATHER IT WAS DELIVERED THROUGH A NEW, SHORT 30CM 18FR COOK INTRODUCER. THE REASONING FOR GOING TROUGH AN 18FR INTRODUCER INCLUDED THE FACT THAT WE HAD PERCUTANEOUS ACCESS AND WE WOULD BE DROPPING TWO FRENCH SIZES WHEN DELIVERING THE SECOND COMPONENT. THE PHYSICIAN WANTED TO MINIMIZE BLEEDING AROUND THE SMALLER SHEATH, SO WE DECIDED TO KEEP IT AN 18 FR. WHICH WAS THE SAME FRENCH SIZE AS THE FIRST DEVICE IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6803123 ↗
• InjuryMar 8, 2017Migration or Expulsion of Device; Difficult to Advance; Migration or Expulsion of Device; Difficult to Advance

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE ALPHA GRAFT WAS PREPPED AND THEN INSERTED OVER THE LUNDERQUIST WIRE. SYSTEM ADVANCED TO JUST PAST THE AORTIC ARCH. DEVICE DEPLOYMENT BEGAN BY UNSHEATHING. PHYSICIAN NOTED IT WAS A BIT HARD TO GET STARTED. ONCE UNSHEATHED THE TRIGGER WIRES WERE RELEASED BY TURNING THE BLACK WIRE RELEASE AND BLUE HANDLE. BOTH WERE FULLY TURNED UNTIL THEY COULD NOT BE TURNED ANYMORE. THE DILATOR WAS THEN ATTEMPTED TO BE TAKEN (WALKED OFF) THE WIRE WHILE LEAVING THE SHEATH IN PLACE. IT WOULD NOT COME BACK SO HE USED TO TROUBLE SHOOTING TECHNIQUE OF OPENING THE HANDLE AND MANUALLY PULLING THE WIRE/HANDLE OFF DELIVERY SYSTEM. ALL FOUR WIRES CAME OUT ON THE HANDLE. TIP OF THE SHEATH WAS AT THE DISTAL END OF THE ALPHA GRAFT. DILATOR WAS HARD TO REMOVE BUT THEN GOT STUCK AT AREA OF THE DISTAL END OF THE GRAFT (JUST ABOVE THE TIP OF SHEATH) HE COULD NOT ADVANCE OR WITHDRAW THE DILATOR OR THE SHEATH. PHYSICIAN FELT THAT A WIRE WAS STILL ON THE DEVICE SOMEHOW. PHYSICIAN THEN INSERTED A CODA BALLOON INTO THE DISTAL END OF GRAFT TO HOLD GRAFT IN PLACE AS HE TRIED TO PULL THE DILATOR AND SHEATH OUT. IT TOOK A FEW HARD PULLS BUT EVENTUALLY THE DILATOR AND SHE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6386735 ↗

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