Zenith Alpha G35396Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002353968), received between Apr 20, 2016 and Aug 1, 2016 — classified as 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2016Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THIS WAS OFF LABEL USE. THE LOCKING MECHANISM ON THE BLUE HANDLE NEEDED TO BE LOOSENED USING FORCEPS. THE BARE METAL STENT DID NOT DEPLOY AFTER BEING UNSHEATHED. IT DID DEPLOY AFTER BEING RESHEATHED AND TWISTED. THE PROCEDURE WAS A SUCCESS AND THE PATIENT IS DOING FINE. 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 5836006 ↗
• Apr 20, 2016Retraction Problem; Activation, Positioning or Separation Problem; Difficult to Advance; Positioning Problem; Difficult to Advance

  DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: DURING STEP 2 THE DEVICE WOULD NOT RETRACT TO RELEASE THE TRIGGER WIRES. THE HANDLE HAD TO BE TAKEN APART TO MANUALLY REMOVE THE TRIGGER WIRES. STEP 2 STILL COULD NOT BE RETRACTED. THE PHYSICIAN THEN ATTEMPTED TO MOVE THE DEVICE AROUND UNTIL THE BARE METAL STENT SPRUNG OPEN AND THEN THE SHEATH GOT CAUGHT ON THE BEAR METAL FIXATION. THE PHYSICIAN WAS ABLE TO PULL BACK THE SHEATH AND REMOVE THE DELIVERY SYSTEM. AT THIS POINT, THE GRAFT WAS NOT WHERE THE PHYSICIAN WANTED IT TO BE. THE PHYSICIAN HAD TO ADD ANOTHER PIECE BECAUSE THE FIRST ONE WAS NOT IN POSITION DUE TO GETTING THE DEVICE DEPLOYED. BY ADDING THE SECOND PIECE THE GRAFT WAS ABLE TO BE DEPLOYED. PATIENT OUTCOME: 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 5590224 ↗

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