Zenith Alpha G35347Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002353470), received between Jan 4, 2018 and Jan 4, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2018Leak/Splash; Leak/Splash

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHILE PREPPING THE ALPHA DEVICE, THE PHYSICIAN PLACED A SYRINGE ON THE STOPCOCK AND STARTED FLUSHING. WE NOTICED A HOLE/CRACK IN THE TUBING OF THE STOPCOCK RIGHT AT THE END WHERE IT CONNECTS TO THE SHEATH. IT WAS LEAKING A LOT. WE TRIED TO TROUBLESHOOT AND PLACE GLUE ON THE HOLE AND IT WORKED FOR A BIT. WE PLACED THE GRAFT UP AND DEPLOYED IT. WHILE ALMOST DONE WE NOTICED THE TUBING LEAKING WITH BLOOD AGAIN. HAD TO WORK FAST SO WE TAKE THE SHEATH OUT. PATIENT WAS OK BUT LOST SOME BLOOD BECAUSE OF THE HOLE IN THE TUBING. PATIENT OUTCOME: BLOOD LOSS.

  Patient problems: Blood Loss

  MAUDE report 7163138 ↗

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