Zenith Alpha G35348Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002353487), received between Oct 5, 2020 and Oct 14, 2020 — classified as 2 deaths.

The most frequently reported specific device problem is “Failure to Advance” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathOct 14, 2020Failure to Advance; Failure to Advance

  FURTHER INFORMATION PROVIDE STATES: LOCATION OF THE PRIMARY ENTRY TEAR DISTAL TO THE LEFT SUBCLAVIAN ARTERY (LSA) DISSECTION EXTENDED FROM JUST DISTAL TO LSA DOWN INTO THE ILIACS, WITH A KNOWN RUPTURE IN THE THORACIC AORTA. ZDEG WAS PLACED PROXIMALLY AT THE DISTAL EDGE OF THE LEFT COMMON CAROTID ARTERY AND DISTALLY IN THE MID-DESCENDING THORACIC AORTA (6-8CM ABOVE THE CELIAC). ZDES WAS PLACED INSIDE THE ZDEG PROXIMALLY AND EXTENDED INTO THE MID ABDOMINAL AORTA. THE RUPTURE THAT WAS TREATED IN THE FIRST CASE, BUT NOT SEEN ON FINAL ANGIO AT THE END OF THE FIRST CASE, WAS AGAIN SHOWN TO HAVE EXTRAVASATION BEING FED FROM FALSE LUMEN FILLING DISTAL TO THE ZDEG. THE ZDES ACCORDIONED OCCURRED WHEN ATTEMPTING TO DELIVER THE ALPHA DEVICE. IT SEEMED TO GET CAUGHT ON THE BARE STENT AND WHEN RECOGNIZED THAT WAS THE RESISTANCE, THE STENT HAD KINKED MOVED OUT AND UP. ZENITH ALPHA DEVICE WS PLACED PROXIMALLY INTO THE ZDEG, DISTALLY BELOW THE ZDES AND BELIEVED TO BE ABOUT THE LEVEL OF THE CELIAC. CHOSE TO COVER AND TRY TO EXCLUDE RUPTURE AS QUICKLY AS POSSIBLE AS CPR HAD BEEN ON GOING FOR AN EXTENDED PERIOD OF TIME, SO NO CONFORMATION ANGIO WAS DONE PRIOR TO PLACEMENT.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 10680241 ↗
• DeathOct 5, 2020Off-Label Use; Failure to Advance; Difficult to Advance; Off-Label Use; Failure to Advance; Difficult to Advance

  ADDITIONAL INFORMATION RECEIVED ON 16OCT2020: LOCATION OF THE PRIMARY ENTRY TEAR DISTAL TO THE LEFT SUBCLAVIAN ARTERY (LSA) DISSECTION EXTENDED FROM JUST DISTAL TO LSA DOWN INTO THE ILIACS, WITH A KNOWN RUPTURE IN THE THORACIC AORTA. ZDEG WAS PLACED PROXIMALLY AT THE DISTAL EDGE OF THE LEFT COMMON CAROTID ARTERY AND DISTALLY IN THE MID-DESCENDING THORACIC AORTA (6-8CM ABOVE THE CELIAC). ZDES WAS PLACED INSIDE THE ZDEG PROXIMALLY AND EXTENDED INTO THE MID ABDOMINAL AORTA. THE RUPTURE THAT WAS TREATED IN THE FIRST CASE, BUT NOT SEEN ON FINAL ANGIO AT THE END OF THE FIRST CASE, WAS AGAIN SHOWN TO HAVE EXTRAVASATION BEING FED FROM FALSE LUMEN FILLING DISTAL TO THE ZDEG. THE ZDES ACCORDIONED OCCURRED WHEN ATTEMPTING TO DELIVER THE ALPHA DEVICE. IT SEEMED TO GET CAUGHT ON THE BARE STENT AND WHEN RECOGNIZED THAT WAS THE RESISTANCE, THE STENT HAD KINKED MOVED OUT AND UP. ZENITH ALPHA DEVICE WAS PLACED PROXIMALLY INTO THE ZDEG, DISTALLY BELOW THE ZDES AND BELIEVED TO BE ABOUT THE LEVEL OF THE CELIAC. CHOSE TO COVER AND TRY TO EXCLUDE RUPTURE AS QUICKLY AS POSSIBLE AS CPR HAD BEEN ON GOING FOR AN EXTENDED PERIOD OF TIME, SO NO CONFORMATION ANGIO WAS DONE PRIOR TO PLACEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cardiac Arrest; Death

  MAUDE report 10626041 ↗

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