Zenith Alpha G35351Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002353517), received between Jan 9, 2020 and Jan 16, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2020Fracture; Fracture

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "THE ZTA-P-34-161-W WAS DEPLOYED IN THE DESCENDING THORACIC AORTA. THERE WAS EVIDENCE OF A TYPE 1B ENDOLEAK ON THE ANGIOGRAM( 3005580113-2020-00057). THE ZTA-P-34-113-W WAS THEN DEPLOYED DISTAL TO 1ST DEVICE. THE ZTA-P-38-117 WAS DEPLOYED PROXIMAL TO THE 1ST DEVICE. PATIENT PRESENTED TO THE ER AT A NEIGHBORING HOSPITAL AND WAS TRANSFERRED FOR AN EMERGENT TBRANCH REPAIR." IT WAS FURTHER REPORTED: "THE FRACTURE WAS DISCOVERED ON (B)(6) 2019. AT THE FINAL ANGIOGRAM, A TYPE IB ENDOLEAK WAS NOTED AND A SECOND STENT GRAFT WAS PLACED DISTAL TO THE GRAFT. A THIRD STENT WAS PLACED TO GET A BETTER SEAL ZONE. TBRANCH WAS NOTED FOR FUTURE TREATMENT IF NECESSARY. THE ENDOLEAK WAS DISCOVERED POST ANGIOGRAM ON THE INITIAL IMPLANT ON (B)(6) 2016. ADDITIONAL STENT WAS PLACED TO RESOLVE ENDOLEAK."

  Patient problems: No Information

  MAUDE report 9596706 ↗
• InjuryJan 14, 2020Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 9584748 ↗
• InjuryJan 14, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "THE ZTA-P-34-161-W WAS DEPLOYED IN THE DESCENDING THORACIC AORTA. THERE WAS EVIDENCE OF A TYPE 1B ENDOLEAK ON THE ANGIOGRAM. THE ZTA-P-34-113-W WAS THEN DEPLOYED DISTAL TO 1ST DEVICE. THE ZTA-P-38-117 WAS DEPLOYED PROXIMAL TO THE 1ST DEVICE. PATIENT PRESENTED TO THE ER AT A NEIGHBORING HOSPITAL AND WAS TRANSFERRED FOR AN EMERGENT BRANCH REPAIR." ADDITIONAL INFORMATION RECEIVED 07JAN2020: AT THE FINAL ANGIOGRAM, A TYPE IB ENDOLEAK WAS NOTED AND A SECOND STENT GRAFT WAS PLACED DISTAL TO THE GRAFT. A THIRD STENT WAS PLACED TO GET A BETTER SEAL ZONE. TBRANCH WAS NOTED FOR FUTURE TREATMENT IF NECESSARY. THE ENDOLEAK WAS DISCOVERED POST ANGIOGRAM ON THE INITIAL IMPLANT ON (B)(6) 2016. ADDITIONAL STENT WAS PLACED TO RESOLVE ENDOLEAK." PATIENT OUTCOME: UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 9584743 ↗
• InjuryJan 9, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  EVENT INFORMATION ACCORDING TO INITIAL REPORTER: "THE ZTA-P-34-161-W WAS DEPLOYED IN THE DESCENDING THORACIC AORTA. THERE WAS EVIDENCE OF A TYPE 1B ENDOLEAK ON THE ANGIOGRAM. THE ZTA-P-34-113-W WAS THEN DEPLOYED DISTAL TO 1ST DEVICE. THE ZTA-P-38-117 WAS DEPLOYED PROXIMAL TO THE 1ST DEVICE. PATIENT PRESENTED TO THE ER AT A NEIGHBORING HOSPITAL AND WAS TRANSFERRED TO DR (B)(6) SERVICE FOR AN EMERGENT T BRANCH REPAIR."

  Patient problems: No Code Available

  MAUDE report 9571608 ↗

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