Zenith Alpha G35357Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002353579), received between Oct 18, 2021 and Dec 4, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionDec 4, 2024Mechanical Jam; Mechanical Jam

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ALPHA GRAFT ADVANCED INTO INTENDED POSITION WITHIN THE THORACIC AORTA. DEPLOYED PER INSTRUCTIONS FOR USE (IFU). WHEN THE PHYSICIAN STARTED TO TURN THE BLACK SAFETY, KNOB IT APPEARED TO TURN FREELY. THE BLUE ROTATION HANDLE ALSO TURNED FREELY AND THE GRAFT WAS NOT RELEASING. THE PHYSICIAN IMMEDIATELY RELEASED THE GRAFT USING THE DOCUMENTED RELEASE TROUBLESHOOTING IFU STEPS PULLED TAB, AND DISASSEMBLED THE HANDLE, WHICH RELEASED THE TRIGGER WIRES. THE DELIVERY SYSTEM WAS SAVED FOR INSPECTION. PATIENT OUTCOME: GRAFT WAS IN GOOD POSITION, AND THE AORTIC REPAIR CONTINUED. PATIENT LEFT THE OPERATING ROOM IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20841227 ↗
• InjuryOct 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: COMPONENT SEPARATION. 2YR CELIAC COMPONENT SEPARATION. ON (B)(6) 2018: TYPE III ENDOLEAK BETWEEN THE BRANCH AND TEVAR REPAIRED WITH GORE CTAG 40X150. ON (B)(6) 2018: COMPONENT SEPARATION REPAIR. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12698887 ↗
• InjuryOct 18, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

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

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12645758 ↗

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