Zenith Alpha G35349Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002353494), received between Sep 27, 2016 and Sep 17, 2024 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Dent in Material” (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. 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.

• MalfunctionSep 17, 2024Failure to Advance; Failure to Advance

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: UPON BEGINNING A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) PROCEDURE WE HAD DIFFICULTY TRACKING A ZTA-P-34-113-W THROUGH THE PATIENTS COMMON ILIAC. A FLEX DEVICE HAD BEEN PREVIOUSLY IMPLANTED 15 YEARS AGO, BUT IT WAS NOT BELIEVED THAT TRACKING THROUGH THE EXISTING DEVICE WAS THE ISSUE. ANGIO BALLOONS WERE UTILIZED AS WELL AS A 18FR DRY SEAL WHICH TRACKED UP POTENTIALLY DUE TO SOME MORE RIGIDITY IN THE SHEATHE. WE CONCLUDED THAT THE ALPHA ITSELF MIGHT HAVE BEEN THE ISSUE. WE DID INSPECT THE DEVICE TO CONFIRM THAT THERE WAS NO SEPARATION BETWEEN THE DILATOR AND SHEATHE AND WE DID ATTEMPT TO INSERT THE DEVICE SEVERAL TIMES UNTIL WE FELT IT WAS NECESSARY TO TRY A BACK UP DEVICE THAT WAS BROUGHT IN THE SAME SIZE. THERE WAS NO ISSUE TRACKING THE NEW DEVICE UP AND A TOTAL OF 3 DEVICES WERE IMPLANTED INTO THE PATIENT, 3 ALPHAS ( ZTA-P-34-113-W, ZTA-36-113-W, ZTA-38-167-W) AND THE INITIAL DEVICE (ZTA-P-34-113-W) WAS NOT USED. ADDITIONAL INFORMATION RECEIVED 22AUG2024: A PREVIOUS EVAR (ENDOVASCULAR AORTIC REPAIR) REPAIR WAS DONE ON THE PATIENT WITH A COOK ZENITH FLEX AAA DEVICE, NO OTHER INFORMATION WAS PROVIDED REGARDING THE SPECIFIC DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20234396 ↗
• InjurySep 12, 2018Positioning Failure; Dent in Material; Difficult to Advance; Positioning Failure; Dent in Material; Difficult to Advance

  DESCRIPTION ACCORDING TO INITIAL REPORTER: "AFTER TAKING AORTOGRAM JUST PROXIMAL TO THE AORTIC BIFURCATION TO DETERMINE THE STATUS OF BOTH RIGHT AND LEFT COMMON ILIAC AND RIGHT AND LEFT EXTERNAL ILIACS PHYSICIAN PLACED A LES .035 260CM GUIDE WIRE THROUGH A KMP CATHETER INTO THE AORTIC ARCH; A PIGTAIL CATHETER PLACED OVER A GLIDE WIRE WAS TO TAKE ANGIOGRAMS INTRA-OP THROUGH A 6FR SHEATH ON RIGHT SIDE COMMON FEMORAL. PHYSICIAN PLACED AN 16FR AND THEN 18FR HYDROPHILIC DILATOR OVER THE LES WIRE GUIDE TO DILATE THE LEFT EXT AND COMMON ILIAC. WE THEN TRIED TO ADVANCE THE ALPHA 34X113 DEVICE BUT COULD NOT GET THE DEVICE PAST MID LEFT COMMON ILIAC; PHYSICIAN TOOK DEVICE OUT AND USED 18FR X 33CM DRY SEAL TO HOLD THE ABBOTT PRO-GLIDE ARTERIOTOMY. HE THEN DECIDED TO BALLOON THE LEFT AND RIGHT COMMON ILIAC WITH 8MM X 40MM BILATERAL KISSING BALLOONS; WE AGAIN TRIED TO ADVANCE THE ALPHA DEVICE BUT FELT IT WAS CATCHING IN THE LOWER LEFT EXTERNAL ILIAC; A 7MM X 120MM EVERCROSS WAS THEN USED TO BALLOON THE ENTIRE LENGTH OF THE LEFT EXTERNAL ILLIAC AND AGAIN WE TRIED TO ADVANCE THE ALPHA DEVICE BUT IT WOULD NOT PASS THROUGH THE LEFT COMMON ILIAC ARTERY. AN 8MM X 80MM BALLOON WAS ALSO USED TO OPEN UP

  Patient problems: Blood Loss; Rupture

  MAUDE report 7867756 ↗
• DeathJan 31, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE GRAFTS WERE PLACED PER IFU WITH IVUS GUIDANCE. POST APPOINTMENT IVUS SURVEILLANCE NOTED RETROGRADE DISSECTION INTO THE ASCENDING AORTA. DISSECTION WAS CONFIRMED WITH TEE THORACIC, SURGERY WAS CONSULTED AND WAS DECIDED BEST TO TRANSFER PATIENT TO A HOSPITAL FOR OPEN ASCENDING AORTIC REPAIR. INFORMATION RECEIVED 09JAN2017: PATIENT FOLLOW UP: PATIENT EXPIRED POST PROCEDURE IN THE RECOVERY ROOM. PATIENT OUTCOME: THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR OPEN ASCENDING AORTIC REPAIR. PATIENT EXPIRED POST PROCEDURE IN THE RECOVERY ROOM.

  Patient problems: Vascular Dissection

  MAUDE report 6288750 ↗
• InjurySep 27, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THIS PATIENT RETURNED WITH TWO WEEKS WITH INFECTED GRAFT AND ULTIMATELY UNDERWENT EXPLANT AND OPEN THORACO-ABDOMINAL REPAIR. NO SIGNS 1ST OF INFECTION ON HER 1ST PRESENTATION BUT GIVEN TIMING ASSUMING THAT HER INITIAL RUPTURE WAS DUE TO INFECTION. ADDITIONAL INFORMATION RECEIVED 09SEP2016: THIS WAS A RUPTURED ANEURYSM PATIENT THAT PRESENTED WITH SYMPTOMS. THE ALPHA DEVICE WAS USED AND THEY HAD A GREAT INTER OPERATIVE RESULT. ADDITIONAL INFORMATION RECEIVED 12SEP2016: PATIENT ADMITTED TO THE HOSPITAL ON (B)(6) 2016 WITH BACK PAIN, FEVER, AND ELEVATED WBC; BLOOD CULTURES + FOR STREP PYOGENES. EXPLANT OCCURRED (B)(6) 2016, SENT TO MICROBIOLOGY - CULTURES DID NOT GROW ANYTHING. AFTER THE EXPLANT, RIFAMPIN SOAKED DACRON GRAFT PLACED. PATIENT OUTCOME: DISCHARGED AFTER LONG POSTOPERATIVE COURSE AT HOME; HAS A PERIAORTIC FLUID COLLECTION MANAGED WITH DRAIN, LAST SEEN DURING BRIEF ADMISSION FOR DRAIN EXCHANGE AND IS ON LONG TERM ANTIBIOTICS (CURRENTLY ON DAPTOMYCIN FOR 6 WEEKS)

  Patient problems: Fever; Pain; Unspecified Infection

  MAUDE report 5979122 ↗

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