Zenith Alpha G35335Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002353357), received between Dec 20, 2021 and May 20, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Off-Label Use” (3 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.

• InjuryMay 20, 2022Entrapment of Device; Entrapment of Device

  DESCRIPTION OF EVENT ACCORDING TO TWEET: TWEET: HAVE YOU EVER SEEN A NEW DISSECTION FLAP INSIDE A STENDT GRAFT? TWEET: I HAVE @WASHUVASCULAR .26 MM @COOKVASCULAR ALPHA PLACED FOR ABERRANT L SCA (LEFT SUBCLAVIAN ARTERY) IN A RIGHT SIDED ARCH. PRESENTED WITH HTN (HYPERTENSION) AND AKI (ACUTE KIDNEY INJURY) TO CLINIC. 50 MMHG PRESSURE DIFFERENTIAL, LOOKED LIKE DELAMINATED THROMBUS ON #IVUS (INTRAVASCULAR ULTRASOUND). PATIENT OUTCOME: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14461609 ↗
• InjuryMay 10, 2022Entrapment of Device; Off-Label Use; Obstruction of Flow; Entrapment of Device; Off-Label Use; Obstruction of Flow

  DESCRIPTION OF EVENT ACCORDING TO TWEET: HAVE YOU EVER SEEN A NEW DISSECTION FLAP INSIDE A STENDT GRAFT? TWEET: I HAVE @WASHUVASCULAR .26 MM @COOKVASCULAR ALPHA PLACED FOR ABERRANT L SCA (LEFT SUBCLAVIAN ARTERY) IN A RIGHT SIDED ARCH. PRESENTED WITH HTN (HYPERTENSION) AND AKI (ACUTE KIDNEY INJURY) TO CLINIC. 50 MMHG PRESSURE DIFFERENTIAL, LOOKED LIKE DELAMINATED THROMBUS ON #IVUS (INTRAVASCULAR ULTRASOUND). PATIENT OUTCOME: UNKNOWN.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 14344583 ↗
• InjuryJan 4, 2022Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT PRESENTED WITH A TYPE B DISSECTION AND PROVIDED DIAMETERS, SIZE, ETC. AFTER THE PHYSICIAN FURTHER REVIEWED THE FILMS, A TYPE A DISSECTION WAS OBSERVED. THE PHYSICIAN DECIDED TO TREAT ASCENDING REPAIR WITH A FROZEN ELEPHANT TRUNK ANAGRADE. SIZES WERE DISCUSSED AND THE PHYSICIAN NEEDED A 26 OR 28, BUT THESE ARE NOT MADE BY COOK (FOR THIS PARTICULAR DEVICE). THE DM CALLED BACK AND STATED HE HAD A 26X105; HOWEVER IN A ALPHA GRAFT. THIS GRAFT WAS USED. IVUS WAS AVAILABLE. NO IMAGING AVAILABLE WHILE PERFORMING THE OPEN PROCEDURE. WHEN THE PHYSICIAN PREPARES TO DELIVER THE GRAFT, THE DM NOTED TO THE PHYSICIAN THAT HE DID NOT HAVE VISIBILITY OF THE GRAFT. THUS, THE DM TOLD THE PHYSICIAN TO MEASURE TO DETERMINE WHERE THE END OF THE GRAFT IS PRECISELY LOCATED. THE GRAFT WAS MEASURED TO REALIZE THE END OF THE GRAFT. AT THIS POINT THE DEVICE WAS DELIVERED AND MOST LIKELY TOO FAR. THE PHYSICIAN WENT TO UN-SHEATH AND THERE WAS A LOT OF TENSION BUILT UP. AS THE PHYSICIAN IS UNSHEATHING, HE IS ACTUALLY PUSHING THE GRAFT FURTHER DOWN THE AORTA. WHEN THE PHYSICIAN IS UN-SHEATHING THE GRAFT, THE PHYSICIAN NOTES HE CAN NOT SEE THE END OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13150974 ↗
• InjuryDec 20, 2021Off-Label Use; Malposition of Device; Device Dislodged or Dislocated; Off-Label Use; Malposition of Device; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13042702 ↗

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