Zenith Alpha G35341Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002353418), received between Sep 9, 2016 and Oct 7, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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.

• InjuryOct 7, 2021Biocompatibility; Biocompatibility

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: SUCCESSFUL CASE AND OUTCOME. PATIENT RETURNED A WEEK LATER WITH INFECTED AORTA. HE WAS QUESTIONED TO HAVE INFECTION BEFORE THE CASE, BUT UNCONFIRMED. PATIENT OUTCOME: THE PATIENT IS SCHEDULED FOR AN ENDOGRAFT EXPLANT OF THE DEVICE ON THE (B)(6) 2021. THE PATIENT HAD AN ENLARGED ANEURISM, HIGH WHITE COUNT.

  Patient problems: Inflammation

  MAUDE report 12590574 ↗
• InjurySep 28, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 12538756 ↗
• InjurySep 28, 2021Biocompatibility; Biocompatibility

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

  Patient problems: Inflammation

  MAUDE report 12538737 ↗
• MalfunctionSep 9, 2016Failure to Advance; Delivery System Failure; Failure to Advance; Delivery System Failure

  DESCRIPTION ACCORDING TO INITIAL REPORTER: LEFT SIDE WAS ACCESSED DILATORS PASSED, UNABLE TO PASS 16 FR. DILATOR. RIGHT SIDE WAS ACCESSED DILATORS PASSED, UNABLE TO PASS 16 FR. DILATOR. VIABAHN STENT 9 MM WAS PLACED AND BALLOONED WITH 9 MM X 4 CM BALLOON THROUGHOUT STENT. DILATORS WERE PASSED AGAIN IN SEQUENTIAL 14 FR., 16 FR., & 18 FR. SUCCESSFULLY. ATTEMPTED TO PASS DEVICE STILL WOULD NOT ADVANCE. REBALLOONED AND REPASSED DILATORS, ATTEMPTED DEVICE AGAIN RIDGES NOTED IN THE SHEATH, DEVICE WOULD NOT ADVANCE. OPENED DIFFERENT DEVICE AND IT PASSED WITHOUT INCIDENCE. PATIENT OUTCOME: 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 5938420 ↗

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