Zenith Alpha G38180Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002381800), received between Apr 20, 2016 and Oct 22, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A FEMALE PATIENT OF UNDISCLOSED AGE UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) DESCENDING THORACIC AORTA PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS, G38180, WAS USED. AFTER UNSHEATHING GRAFT AND DISTAL TRIGGER WIRE RELEASE FROM GRAFT, DISTAL END OF GRAFT DID NOT OPEN COMPLETELY. BALLOON WAS PLACED IN DISTAL PART OF GRAFT AND INFLATED TO OPEN GRAFT COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20503523 ↗
• InjuryFeb 2, 2024Activation Failure; Activation Failure

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER. A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) PROCEDURE IN WHICH THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS, WAS USED. WHEN THE GRAFT WAS UNSHEATHED IN THE PATIENT THE THIRD STENT FROM THE TOP WOULD NOT OPEN FULLY. IT WAS CONSTRAINED ABOUT FIFTY PERCENT. THE SURGEON USED A CODA BALLOON TO OPEN THE STENT SUCCESSFULLY. IT WAS A DISSECTION, PATIENT HAD SOME TEARS IN THEIR AORTA PATIENT OUTCOME: DISTRICT MANAGER CONTACTED THE SURGEON ONE DAY POST-OP AND SURGEON CONFIRMED THE PATIENT WAS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630473 ↗
• InjuryJan 30, 2024Off-Label Use; Activation Failure; Off-Label Use; Activation Failure

  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 18605230 ↗
• MalfunctionMar 18, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  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 11515020 ↗
• MalfunctionMar 12, 2020Use of Device Problem; Failure to Advance; Physical Resistance/Sticking; Use of Device Problem; Failure to Advance; Physical Resistance/Sticking

  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; No Consequences Or Impact To Patient

  MAUDE report 9823143 ↗
• Apr 20, 2016Leak/Splash

  DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: "PROXIMAL ZENITH ALPHA DEVICE IMPLANTED WAS A ZTA-PT-38-34-167-W, DISTAL COMPONENT WAS A ZTA-P-24-105-W. DISTAL COMPONENT IMPLANTED FIRST TO COMPENSATE FOR DIAMETERS ON OVERLAP. APPROXIMATE OVERLAP BETWEEN THE TWO GRAFTS WAS 7CM, OR A LITTLE MORE THAN 3 STENTS. UPON IMPLANTATION, CODA BALLOONING WITH A 40MM CODA BALLOON WAS PERFORMED TO A NOMINAL PRESSURE THROUGHOUT THE DEVICE, IN ALL SEGMENTS. UPON COMPLETION OF BALLOONING, A DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WAS PERFORMED WITH A PIGTAIL FLUSH CATHETER, FLUSHPORTS JUST PROXIMAL TO THE FABRIC. AN EARLY DETECTION OF AN ENDOLEAK WAS PRESENT IN THE ANEURYSM SAC, HOWEVER ITS SOURCE WAS INDETERMINATE. WE REBALLOONED THE ENTIRE DEVICE, THIS TIME APPLYING MORE THAN NOMINAL PRESSURE IN THE MOST PROXIMAL ZONE, OVERLAP JUNCTION, AND DISTAL ZONE, AS THOSE WERE THE MOST LIKELY CAUSES OF AN EARLY ONSET ENDOLEAK. ADDITIONAL DSA REVEALED THE SAME ENDOLEAK. CONFIDENT THAT THE LEAK WAS NOT A 1A ENDOLEAK AS THE DEVICE WAS SITTING NICELY IN THE PROXIMAL SEGMENT, WE MOVED THE PIGTAIL CATHETER INTO THE MIDDLE OF THE DEVICE, AS WE THOUGHT THE SOURCE COULD BE A TYPE 3 DUE TO THE OVERLAP JUNCTION, PRIMARI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5590097 ↗

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