Zenith Alpha G35333Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002353333), received between Oct 2, 2017 and Jul 14, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2021Off-Label Use; Obstruction of Flow; Off-Label Use; Obstruction of Flow

  ADDITIONAL INFORMATION RECEIVED 13OCT2021: EMERGENCY RESECTION AND GRAFT REPLACEMENT OF THE DESCENDING THORACIC AORTA USING CARDIO CORONARY BYPASS SUPPORT. OPERATIVE FINDINGS: THE STENT GRAFT WAS A LITTLE BIT FOLDED BUT HAD GOOD TISSUE APPOSITION IN THE PROXIMAL AND DISTAL LANDING ZONES. PT WAS BASICALLY TOTALLY OBSTRUCTED WITH THE DISTAL INTRALUMINAL THROMBUS WHICH WAS WELL-ORGANIZED AND OBVIOUSLY CHRONIC. NO FEMORAL BLOOD PRESSURE AT THE BEGINNING OF THE OPERATION.

  Patient problems: Diarrhea; Headache; Heart Failure/Congestive Heart Failure; Paraplegia; Pleural Effusion; Renal Failure; Thrombosis/Thrombus

  MAUDE report 12165626 ↗
• InjuryJul 9, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE INITIAL REPORTER, IT IS ALLEGED THAT [PT] RECEIVED A COOK ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL ON (B)(6) 2018 IN HIS MID-DESCENDING THORACIC AORTA. ON (B)(6) 2019, [PT] PRESENTED TO HOSPITAL WITH VOMITING, DIARRHEA, BACK PAIN, THIGH PAIN AND HEADACHE. AT THAT TIME, HE WAS ADMITTED. HE WAS FOUND TO BE IN ACUTE RENAL FAILURE WITH BILATERAL PLEURAL EFFUSIONS. HE CONTINUED TO HAVE PULMONARY AND RENAL INSUFFICIENCY AND WAS THEN TRANSFERRED BY AMBULANCE TO ANOTHER HOSPITAL FOR A HIGHER LEVEL OF CARE. ON (B)(6) 2019, PHYSICIAN PERFORMED AN EMERGENCY RESECTION AND GRAFT REPLACEMENT OF THE DESCENDING THORACIC AORTA USING CARDIO CORONARY BYPASS SUPPORT AND CRYO-ANALGESIA OF INTERCOSTAL NERVES III THROUGH VI ON [PT]. THE PREOPERATIVE AND POSTOPERATIVE DIAGNOSIS WAS THROMBOSED DESCENDING THORACIC STENT GRAFT WITH ACUTE KIDNEY FAILURE, ACUTE CONGESTIVE HEART FAILURE, ACUTE PARAPLEGIA FROM SPINAL ISCHEMIA AND RESPIRATORY FAILURE.

  Patient problems: Headache

  MAUDE report 12142725 ↗
• InjuryMar 6, 2018Occlusion Within Device; Occlusion Within Device

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT FORMED DISTAL THROMBUS AND THE STENT BECAME INCLUSIVE CAUSING PARALYSIS OF THE LEGS. THIS REQUIRED A RE-INTERVENTION WITH A GORE ENDOGRAFT WHICH SEEMS TO HAVE OPENED THE LUMEN BUT THE PATIENT SEEMS TO STILL HAVE SOME PARALYSIS. PATIENT OUTCOME: THE PATIENT REQUIRED ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE, RE-INTERVENTION WITH ENDOGRAFT. PARALYSIS OF THE LEGS.

  Patient problems: Paraplegia

  MAUDE report 7315684 ↗
• InjuryOct 2, 2017Leak/Splash; Occlusion Within Device; Leak/Splash; Occlusion Within Device

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "GLOBAL PRODUCT MANAGER, WAS ATTENDING THE (B)(6) MEETING, DURING WHICH, A PHYSICIAN, PRESENTED A CASE UTILIZING THE ZENITH ALPHA DEVICE. THE CASE WAS PRESENTING THE USE OF THE ZENITH ALPHA DEVICE IN AN OFF LABEL MANNER, TREATING AN AORTIC COARCTATION. DURING THE FOLLOW-UP IMAGING, THERE LOOKED TO BE A TYPE 2 OR 3 LEAK AS WELL AS SOME THROMBUS BUILT-UP IN THE GRAFT. THIS EVENT CAUSED SOME CONCERN ABOUT THE THROMBUS AS WELL AS IF THE LEAK WAS A TYPE 3 ENDOLEAK (TEAR IN THE GRAFT). THE GRAFT UTILIZED WAS A 24MM GRAFT AND WAS DILATED WITH A 14MM NON-COMPLIANT PTA BALLOON, BUT NOTHING LARGER. IT IS UNKNOWN HOW THE PHYSICIAN WILL BE TREATING THIS, BUT THE AUDIENCE RECOMMENDED CONTINUED FOLLOW-UP. THIS COMPLAINT WAS ENTIRELY FROM THE PERSPECTIVE OF GLOBAL PRODUCT MANAGER, WHOM WAS PRESENT FOR THE MEETING. ADDITIONAL INFORMATION RECIEVED 18SEP2017: "THE DEVICE WAS USED IN AN OFF-LABEL MANNER BY TREAT AN AORTIC COARCTATION, WHICH THE DEVICE IS NOT INDICATED. THE TYPE OF ENDOLEAK HAS NOT BEEN FURTHER DETERMINED/ANALYZED AND TREATMENT AT THIS TIME IS FOR A FOLLOW-UP CT AT 6 MONTHS. "PHYSICIAN WAS EVALUATING WHAT THE NEXT STEPS WOULD BE TO M

  Patient problems: Thrombosis

  MAUDE report 6908262 ↗

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