Zenith Alpha G35375Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10827002353753), received between Apr 9, 2019 and Jan 13, 2022 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Tipped Over” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2022Obstruction of Flow; Obstruction of Flow

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THERE IS A MODERATE AMOUNT OF LUMINAL THROMBUS WITHIN THE ALPHA GRAFT ((B)(4)). PER (B)(4) MANUFACTURER REPORT# 3002808486-2021-01880: "COMPONENT SEPARATION. NEAR ZERO OVERLAP. COMPONENT SEPARATION, LATEST IMAGING AVAILABLE." ON (B)(6) 2017: RESECTION OF ISCHEMIC PORTION OF SIGMOID COLON WITHOUT ANASTOMOSIS. SMA THROMBECTOMY, LEFT ILIAC TO COMMON HEPATIC AND SUPERIOR MESENTERIC ARTERY (SMA) BYPASS WITH 14X7 BIFURCATED HEMASHIELD GOLD GRAFT, LEFT SIGMOID COLECTOMY AND CHOLECYSTECTOMY. ON (B)(6) 2017: EXPLORATORY LAP, LEFT HEMICOLECTOMY, OPEN ABDOMEN. ON (B)(6) 2017: EXPLORATORY LAPAROTOMY, REMOVAL OF FIVE 12 X 12 SURGICAL PADS AND PLACEMENT OF 5 NEW 16 X 16 SURGICAL PACKS, 2 IN THE SPLENIC BED, 2 IMMEDIATELY ANTERIOR TO THE PANCREAS IN THE RETROPERITONEUM, AND 1 WITHIN THE GALLBLADDER FOSSA. PATIENT OUTCOME: PATIENT EXPIRED ON (B)(6) 2017.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13251001 ↗
• InjuryJan 4, 2022Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THERE IS A MODERATE AMOUNT OF LUMINAL THROMBUS WITHIN THE ALPHA GRAFT ((B)(4)). PER (B)(4) MANUFACTURER REPORT# 3002808486-2021-01880: "COMPONENT SEPARATION. NEAR ZERO OVERLAP. COMPONENT SEPARATION, LATEST IMAGING AVAILABLE." ON (B)(6) 2017: RESECTION OF ISCHEMIC PORTION OF SIGMOID COLON WITHOUT ANASTOMOSIS. SMA THROMBECTOMY, LEFT ILIAC TO COMMON HEPATIC AND SUPERIOR MESENTERIC ARTERY (SMA) BYPASS WITH 14X7 BIFURCATED HEMASHIELD GOLD GRAFT, LEFT SIGMOID COLECTOMY AND CHOLECYSTECTOMY. ON (B)(6) 2017: EXPLORATORY LAP, LEFT HEMICOLECTOMY, OPEN ABDOMEN. ON (B)(6) 2017: EXPLORATORY LAPAROTOMY, REMOVAL OF FIVE 12 X 12 SURGICAL PADS AND PLACEMENT OF 5 NEW 16 X 16 SURGICAL PACKS, 2 IN THE SPLENIC BED, 2 IMMEDIATELY ANTERIOR TO THE PANCREAS IN THE RETROPERITONEUM, AND 1 WITHIN THE GALLBLADDER FOSSA. PATIENT OUTCOME: PATIENT EXPIRED ON (B)(6) 2017.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13151118 ↗
• InjuryNov 19, 2021Device Tipped Over; Device Tipped Over

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12842924 ↗
• InjuryNov 15, 2021Device Tipped Over; Device Tipped Over

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A FEMALE PATIENT OF UNDISCLOSED AGE UNDERWENT A COMPLEX ENDOVASCULAR AORTIC ARCH REPAIR PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS, G35375, WAS USED. THE PHYSICIAN NEEDED TO PLACE A 46MM ALPHA GRAFT TO PROVIDE OVERLAP BETWEEN AN EXISTING TEVAR GRAFT AND A CMD GRAFT. THE 46 ALPHA DEVICE WAS PLACED IN A GOOD POSITION PROVIDING GOOD OVERLAP BETWEEN THE 2 GRAFTS. DEPLOYMENT OF THE GRAFT WAS PER IFU. WHEN RELEASING THE PROFORM ATTACHMENT- THE GRAFT APPEARED TO FOLD UPON ITSELF AT THE PROXIMAL END (WHERE PROFORM IS LOCATED). THE PHYSICIAN WAS ABLE TO FORCE THE GRAFT INTO PROPER POSITION (UNFOLD THE PROXIMAL END) WITH A MOLDING BALLOON. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION 20OCT2021: NO PLANNING AVAILABLE. MD WAS NOT HAPPY WITH THE PROXIMAL LANDING ZONE OF THE CMD DEVICE AND DECIDED TO ADD AN ADDITIONAL GRAFT TO COVER THE PROXIMAL EDGE OF CMD. THE PROXIMAL LANDING ZONE WAS IN A STRAIGHT SEGMENT OF AORTA. THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12814467 ↗
• InjuryNov 12, 2021Device Tipped Over; Device Tipped Over

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A FEMALE PATIENT OF UNDISCLOSED AGE UNDERWENT A COMPLEX ENDOVASCULAR AORTIC ARCH REPAIR PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS, G35375, WAS USED. THE PHYSICIAN NEEDED TO PLACE A 46MM ALPHA GRAFT TO PROVIDE OVERLAP BETWEEN AN EXISTING TEVAR GRAFT AND A CMD GRAFT. THE 46 ALPHA DEVICE WAS PLACED IN A GOOD POSITION PROVIDING GOOD OVERLAP BETWEEN THE 2 GRAFTS. DEPLOYMENT OF THE GRAFT WAS PER IFU. WHEN RELEASING THE PROFORM ATTACHMENT- THE GRAFT APPEARED TO FOLD UPON ITSELF AT THE PROXIMAL END (WHERE PROFORM IS LOCATED). THE PHYSICIAN WAS ABLE TO FORCE THE GRAFT INTO PROPER POSITION (UNFOLD THE PROXIMAL END) WITH A MOLDING BALLOON. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION 20OCT2021: NO PLANNING AVAILABLE. MD WAS NOT HAPPY WITH THE PROXIMAL LANDING ZONE OF THE CMD DEVICE AND DECIDED TO ADD AN ADDITIONAL GRAFT TO COVER THE PROXIMAL EDGE OF CMD. THE PROXIMAL LANDING ZONE WAS IN A STRAIGHT SEGMENT OF AORTA. THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807029 ↗
• InjuryOct 22, 2021Off-Label Use; Device Tipped Over; Off-Label Use; Device Tipped Over

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A FEMALE PATIENT OF UNDISCLOSED AGE UNDERWENT A COMPLEX ENDOVASCULAR AORTIC ARCH REPAIR PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS, G35375, WAS USED. THE PHYSICIAN NEEDED TO PLACE A 46MM ALPHA GRAFT TO PROVIDE OVERLAP BETWEEN AN EXISTING TEVAR GRAFT AND A CMD GRAFT. THE 46 ALPHA DEVICE WAS PLACED IN A GOOD POSITION PROVIDING GOOD OVERLAP BETWEEN THE 2 GRAFTS. DEPLOYMENT OF THE GRAFT WAS PER IFU. WHEN RELEASING THE PROFORM ATTACHMENT- THE GRAFT APPEARED TO FOLD UPON ITSELF AT THE PROXIMAL END (WHERE PROFORM IS LOCATED). THE PHYSICIAN WAS ABLE TO FORCE THE GRAFT INTO PROPER POSITION (UNFOLD THE PROXIMAL END) WITH A MOLDING BALLOON. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12679447 ↗
• MalfunctionJun 21, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8721097 ↗
• MalfunctionApr 9, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "ALPHA DEVICE USED FOR A THORACIC ANEURYSM. THE GRAFT DEPLOYED FINE, BUT THE TRIGGER WIRES DID NOT FULLY RETRACT. THE BLUE HANDLE IS VERY DIFFICULT TO TURN AND MAKES A LOUD CLICKING SOUND IF YOU TRY TO RETRACT THE WIRES ANY FURTHER." ADDITIONAL INFORMATION RECEIVED 04/01/2019: "THE SAFETY LOCK KNOW WAS TURNED TO THE UNLOCKED POSITION PRIOR TO ROTATING THE BLUE HANDLE. PROXIMAL STENT APPOSITION WAS LIMITED. TROUBLESHOOTING DID NOT OCCUR". 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 Consequences Or Impact To Patient

  MAUDE report 8495072 ↗

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