Zenith Alpha G35369Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002353692), received between May 3, 2018 and Dec 16, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Tipped Over” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2022Device Tipped Over; Device Tipped Over

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: UPON DEPLOYMENT OF THE DEVICE, THE PROXIMAL EDGE OF THE GRAFT WAS TIPPED SIDEWAYS. THEY SUCCESSFULLY COMPLETED THE PROCEDURE BY REMOVING THE DELIVERY SYSTEM AND BALLOONING THE PROXIMAL EDGE OF THE GRAFT TO GET IT TO OPPOSE THE AORTIC WALL. 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 15996529 ↗
• InjuryDec 7, 2022Device Tipped Over; Device Tipped Over

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: UPON DEPLOYMENT OF THE DEVICE, THE PROXIMAL EDGE OF THE GRAFT WAS TIPPED SIDEWAYS. THEY SUCCESSFULLY COMPLETED THE PROCEDURE BY REMOVING THE DELIVERY SYSTEM AND BALLOONING THE PROXIMAL EDGE OF THE GRAFT TO GET IT TO OPPOSE THE AORTIC WALL. 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 15930105 ↗
• InjuryMay 3, 2018Kinked; Activation, Positioning or Separation Problem; Kinked; Activation, Positioning or Separation Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "THE DEVICE, UPON DEPLOYMENT (SPECIFICALLY DEPLOYMENT OF THE TRIGGER WIRES) ENFOLDED ON ITSELF. DEVICE WAS IN THE PATIENT ALREADY, AND ENFOLDED IN A WAY THAT ANOTHER PIECE WAS ADDED AND WHICH EXTENDED BOTH PROXIMALLY AND DISTALLY FROM THE ORIGINAL DEVICE; THIS BYPASSED THE ENFOLDING ISSUE. PHYSICIAN DETERMINED IT WOULD BE TOO DANGEROUS TO TRY TO STRAIGHTEN BY THE BALLOON". PATIENT OUTCOME: THE FAILING DEVICE DID MAKE THE AORTA SMALLER.

  Patient problems: No Code Available

  MAUDE report 7482247 ↗

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