Zenith Alpha G35404Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002354040), received between Sep 14, 2017 and Sep 14, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2017Difficult or Delayed Positioning; Kinked; Difficult or Delayed Positioning; Kinked

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "THE TRIGGER WIRE AT THE TRI-FOLD OF THE DISTAL PIECE, DID NOT RELEASE. UPON REMOVING THE DELIVERY SYSTEM THE DEVICE IN-FOLDED. PERFORMED A FOLLOW UP WITH THE PHYSICIAN ON (B)(6) 2017 AND THE PHYSICIAN INDICATED THE PATIENT IS DOING WELL." ADDITIONAL INFORMATION RECEIVED 01SEP2017: "THE ISSUE WAS NOT WITH THE BARE STENT OF THE DISTAL GRAFT AT ALL. AFTER THE BARE STENT IS DEPLOYED, THE BLUE HANDLE THEN IS ABLE TO ROTATE AGAIN TO RELEASE THE REMAINING TRIGGER WIRES AT THE TOP OF THE GRAFT (THEY HOLD THE TOP OF THE DISTAL GRAFT IN A CONSTRAINED FORM). THE SURGEON ROTATED THE HANDLE AND SAID HE FELT A STOP. HE CHOSE NOT TO VIEW THIS STEP UNDER FLUOROSCOPY. THE NEXT STEP THEN IS TO REMOVE THE DILATOR. WHEN THE SURGEON BEGAN REMOVING THE DILATOR HE DID NOT REALIZE THE TRIGGER WIRE WAS NOT RELEASED; EFFECTIVELY PULLING THE TOP OF THE GRAFT TO MEET THE BOTTOM OF THE GRAFT. ONCE HE SAW THE GRAFT HAD BEEN INFOLDED, HE WAS ABLE TO TURN THE HANDLE MORE. THIS ACTION RELEASED THE TRIGGER WIRES, AND WE WERE ABLE TO REMOVE THE DILATOR SO TROUBLESHOOTING TO REMOVE THE TRIGGER WIRES WAS NOT NECESSARY." PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6864165 ↗

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