Zenith Alpha G35395Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002353951), received between Jun 13, 2018 and Dec 15, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 15, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE FIRST KNOB ON THE DISTAL COMPONENT GETS LOOSENED. ON THE SECOND KNOB, IT WOULD NOT LOOSEN. HAD TO USE HEMOSTATS TO LOOSEN THE SECOND KNOB. ON THE NUMBER 2 SECTION ONE IS SUPPOSE TO EASILY SLIDE IT BACK AND THEN A CLICK IS HEARD. HOWEVER, THIS WAS NOT THE CASE. THE PHYSICIAN HAD TO USE ALL HIS STRENGTH TO MOVE IT TO WHERE IT WOULD SNAP-IN. THE GRAFT MOVED UP IN THE SHEATH A LITTLE. THE GRAFT WAS ULTIMATELY USED AND IMPLANTED INTO THE SHEATH. THE PHYSICIAN'S LANDING ZONE WAS A LITTLE LOWER THAN WHAT HE WOULD HAVE LIKED. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11010604 ↗
• MalfunctionDec 7, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE FIRST KNOB ON THE DISTAL COMPONENT GETS LOOSENED. ON THE SECOND KNOB, IT WOULD NOT LOOSEN. HAD TO USE HEMOSTATS TO LOOSEN THE SECOND KNOB. ON THE NUMBER 2 SECTION ONE IS SUPPOSE TO EASILY SLIDE IT BACK AND THEN A CLICK IS HEARD. HOWEVER, THIS WAS NOT THE CASE. THE PHYSICIAN HAD TO USE ALL HIS STRENGTH TO MOVE IT TO WHERE IT WOULD SNAP-IN. THE GRAFT MOVED UP IN THE SHEATH A LITTLE. THE GRAFT WAS ULTIMATELY USED AND IMPLANTED INTO THE SHEATH. THE PHYSICIAN'S LANDING ZONE WAS A LITTLE LOWER THAN WHAT HE WOULD HAVE LIKED. PATIENT OUTCOME: 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; No Consequences Or Impact To Patient

  MAUDE report 10963803 ↗
• InjuryJun 13, 2018Difficult to Remove; Difficult to Remove

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "ALPHA DEVICE IMPLANTED SUCCESSFULLY AND POSITIONED WELL. UPON TRYING TO REMOVE PIGTAIL CATHETER AFTER DEPLOYMENT, SEEMED BARE STENT CAUGHT PIGTAIL. ABLE TO ADVANCE PIGTAIL UP EASILY BUT LOTS OF TENSION TO REMOVE PIGTAIL. SUCCESSFULLY REMOVED PIGTAIL BUT DISTAL BARE STENT THEN POSITIONED IN AN UNFAVORABLE POSITION AS APEX OF RIGHT STENTS POINTED AGAINST AORTIC WALL." ADDITIONAL INFORMATION RECEIVED 25MAY2018: "THE BARE STENT WAS AGAINST THE AORTIC WALL BUT WE DID NOT REMOVE THE PIGTAIL WHEN DEPLOYING THE BARE STENT. THEREFORE IT GOT TRAPPED AND THIS HASN¿T CAUSED ANY ISSUE IN THE PAST. IN THIS INSTANCE THE FLUSH PORT ON THE CATHETER SEEMED TO HAVE GOT LODGED ONTO THE FIXATION OF THE BARE STENT. OUTCOME OF PROCEDURE WAS SUCCESSFUL FROM ANEURYSM SEAL. THE WAY THE BARE STENT IS NOW SITTING JUST ISN¿T IDEAL". 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 Code Available

  MAUDE report 7595139 ↗

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