Zenith Alpha G35367Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002353678), received between Mar 6, 2018 and Apr 8, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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.

• InjuryApr 8, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A (B)(6) YEAR OLD MALE PATIENT UNDERWENT A TVAR PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS, G35367, WAS USED. THE LAST GRAFT PIECE, G35367, WAS USED FOR BRIDGING BETWEEN TWO GRAFTS AS THE PROXIMAL GRAFT WAS TOO SHORT WITH THE DISTAL PIECE. WHEN THE PHYSICIAN FINISHED AND ROTATED THE DELIVERY SYSTEM THE NOSE CONE OF THE DEVICE INNER WHITE CANNULA CAME OFF AND STAYED ON THE WIRE END OF THE GRAFT. LEAVING THE NOSE CONE AND INNER CANNULA IN THE PATIENT. THE PHYSICIAN THEN ADVANCED A LONGER AND LARGER SHEATH AND SNARED THE SHEATH TO REMOVE FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED 20MAR2020: AFTER RELEASING THE STENT GRAFT, THE PHYSICIAN RETRIEVED THE INNER SYSTEM AND LEFT THE OUTER SHEATH IN ORDER TO PERFORM BALLOONING. WHEN THE INNER SYSTEM WAS TAKEN OUT, IT WAS NOTED THAT THE SYSTEM ONLY CONTAINED THE GREY POSITIONER ALONG WITH THE HANDLE AND THE TIP ASSEMBLY (DILATOR TIP AND CANNULA) WAS LEFT IN PATIENT. THERE WAS VERY TORTUROUS ANATOMY AND WE WERE WELL IN THE ARCH AROUND ZONE 2. SOME DIFFICULTY RETRIEVING DEVICE OVER THE ARCH BUT AS EXPECTED WITH THE ANATOMY AND SIZE OF ANEURYSM. PA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9937424 ↗
• InjuryApr 1, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A (B)(6) OLD MALE PATIENT UNDERWENT A TVAR PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS, G35367, WAS USED. THE LAST GRAFT PIECE, (B)(4), WAS USED FOR BRIDGING BETWEEN TWO GRAFTS AS THE PROXIMAL GRAFT WAS TOO SHORT WITH THE DISTAL PIECE. WHEN THE PHYSICIAN FINISHED AND ROTATED THE DELIVERY SYSTEM THE NOSE CONE OF THE DEVICE INNER WHITE CANNULA CAME OFF AND STAYED ON THE WIRE END OF THE GRAFT. LEAVING THE NOSE CONE AND INNER CANNULA IN THE PATIENT. THE PHYSICIAN THEN ADVANCED A LONGER AND LARGER SHEATH AND SNARED THE SHEATH TO REMOVE FROM THE PATIENT. ADDITIONAL INFORMATION RECEIVED 20MAR2020: AFTER RELEASING THE STENT GRAFT, THE PHYSICIAN RETRIEVED THE INNER SYSTEM AND LEFT THE OUTER SHEATH IN ORDER TO PERFORM BALLOONING. WHEN THE INNER SYSTEM WAS TAKEN OUT, IT WAS NOTED THAT THE SYSTEM ONLY CONTAINED THE GREY POSITIONER ALONG WITH THE HANDLE AND THE TIP ASSEMBLY (DILATOR TIP AND CANNULA) WAS LEFT IN PATIENT. THERE WAS VERY TORTUROUS ANATOMY AND WE WERE WELL IN THE ARCH AROUND ZONE 2. SOME DIFFICULTY RETRIEVING DEVICE OVER THE ARCH BUT AS EXPECTED WITH THE ANATOMY AND SIZE OF ANEURYSM. PATIENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9909215 ↗
• MalfunctionMar 6, 2018Activation Failure; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THEY PUT THE DEVICE IN THE PATIENT AND DECIDED THEY WANTED A LONGER PIECE AND TOOK IT OUT. THEY THOUGHT IT WOULD BE GOOD TO USE THE DEVICE AS A TEACHING OPPORTUNITY. THE PHYSICIAN DEPLOYED PRODUCT ON THE BACK TABLE. AFTER ALL TRIGGER WIRES WERE REMOVED, THE DEVICE REMAINED CONSTRAINED. THERE WAS A SUTURE THAT SHOULD PRE-FORM; HOWEVER, IT DID NOT EXPAND. IT WAS CONSTRAINED. 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 7315672 ↗

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