Zenith Alpha G35355Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002353555), received between Jan 7, 2020 and Oct 22, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryOct 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: COMPONENT SEPARATION. OVERLAP SECTION NOT INCLUDED IN SCAN RANGE. COMPONENT SEPARATION, ON (B)(6) 2018: THORACIC ENDOGRAFT GORE 40X150. COMPONENT SEPARATION REPAIR. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12680696 ↗
• InjuryOct 18, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IMPLANT PROCEDURE: ON (B)(6) 2017 WITH ZTA A FEN-THORACO-ABDOMINAL-GRAFT (CMD). COMPONENT SEPARATION: (B)(6) 2018.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12645647 ↗
• InjuryJan 8, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INITIAL REPORTER EVENT DESCRIPTION: ALPHA DEVICE USED FOR A THORACIC ANEURYSM. LOOKS LIKE A TYPE 3 ENDOLEAK AT STEEPEST CURVE OF THE ARCH. REINTERVENTION ON (B)(6) 2019 TO IMPLANT ANOTHER ALPHA (ZTA-P-38-167-W) TO SEAL OFF LEAK. THE PATIENT NO LONGER HAS A LEAK. FIRST IMPLANT WAS TUESDAY, (B)(6) 2019. THE DOCTOR SCANNED THE PATIENT (B)(6) 2019 AND SAW AN ENDOLEAK. HE WASN¿T SURE IF IT WAS A TYPE 1A OR TYPE 3. HE LINED THE GRAFT WITH A NEW ALPHA ON (B)(6) 2019. THE PATIENT DOES NOT HAVE A LEAK ANY MORE. THE GRAFT LANDED IN ZONE 2, JUST DISTAL TO THE CAROTID ARTERY. PATIENT OUTCOME: THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE: AN ADDITIONAL IMPLANT OF AN ALPHA DEVICE WAS SCHEDULED FOR (B)(6) 2019 TO SEAL OFF ENDOLEAK. A ZTA-P-38-167-W WAS IMPLANTED ON (B)(6) 2019. DOCTOR IS HAPPY WITH FINAL RESULT.

  Patient problems: No Code Available

  MAUDE report 9566050 ↗
• InjuryJan 7, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ALPHA DEVICE USED FOR A THORACIC ANEURYSM. LOOKS LIKE A TYPE 3 ENDOLEAK AT STEEPEST CURVE OF THE ARCH. REINTERVENTION ON (B)(6) 2019 TO IMPLANT ANOTHER ALPHA (ZTA-P-38-167-W) TO SEAL OFF LEAK. THE PATIENT NO LONGER HAS A LEAK. FIRST IMPLANT WAS TUESDAY, (B)(6) 2019. THE DOCTOR SCANNED THE PATIENT (B)(6) 2019 AND SAW AN ENDOLEAK. HE WASN¿T SURE IF IT WAS A TYPE 1A OR TYPE 3. HE LINED THE GRAFT WITH A NEW ALPHA ON (B)(6) 2019. THE PATIENT DOES NOT HAVE A LEAK ANY MORE. THE GRAFT LANDED IN ZONE 2, JUST DISTAL TO THE CAROTID ARTERY. PATIENT OUTCOME: THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE: AN ADDITIONAL IMPLANT OF AN ALPHA DEVICE WAS SCHEDULED FOR (B)(6) 2019 TO SEAL OFF ENDOLEAK. A ZTA-P-38-167-W WAS IMPLANTED ON (B)(6) 2019. DOCTOR IS HAPPY WITH FINAL RESULT. HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS: NO.

  Patient problems: No Code Available

  MAUDE report 9556580 ↗

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