Zenith Spiral-Z G55222Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002552224), received between Sep 22, 2016 and Oct 10, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Obstruction of Flow” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2025Device Endoleak; Device Endoleak

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

  Patient problems: Clinical Endoleak; Pain

  MAUDE report 23270846 ↗
• InjuryApr 13, 2023Obstruction of Flow; Obstruction of Flow

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

  Patient problems: Obstruction/Occlusion

  MAUDE report 16734443 ↗
• InjuryFeb 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THERE WAS OCCLUSION OF THE RIGHT ILIAC ZENITH LEG GRAFT PLACED IN THE RIGHT COMMON ILIAC ARTERY. THIS REPORT IS RELATED TO ANOTHER MDR WITH PATIENT IDENTIFIER : (B)(6). THE PATIENT WAS ENROLLED IN STUDY 14-09. AT THE TIME OF ENROLLMENT, PRE-PROCEDURE IMAGING CONDUCTED BY THE SITE NOTED A STABLE JUXTA RENAL AORTIC ANEURYSM. THE PROXIMAL SEALING ZONE SHOWED NO CALCIFICATION, OCCLUSIVE DISEASE, OR THROMBUS. THERE WAS NO CALCIFICATION, OCCLUSIVE DISEASE OF THE BILATERAL COMMON AND EXTERNAL ILIAC ARTERIES. THERE WAS NO TORTUOSITY OF THE BILATERAL ILIAC ARTERIES. INDEPENDENT LAB ANALYSIS NOTED AN ANEURYSM DIAMETER OF 58.3 MM. THE PROXIMAL SEALING ZONE WAS PARALLEL SHAPED AND SHOWED NO CALCIFICATION, OCCLUSIVE DISEASE, OR THROMBUS. THE INDEPENDENT LAB ALSO CONFIRMED THAT THERE WAS NO CALCIFICATION OR OCCLUSIVE DISEASE OF THE BILATERAL COMMON ILIAC ARTERIES. THE INDEPENDENT LAB STATED THERE WAS MILD TORTUOSITY OF THE BILATERAL ILIAC ARTERIES. THERE WAS NO CALCIFICATION OR OCCLUSIVE DISEASE OF THE RIGHT EXTERNAL ILIAC ARTERY. THERE WAS MILD CALCIFICATION BUT NO OCCLUSIVE DISEASE OF THE LEFT EXTERNAL ILIAC ARTERY. ON (B)(6) 2018, THE PATIENT UNDERWENT AN ENDOVASCULAR AOR

  Patient problems: Insufficient Information; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 13538749 ↗
• InjurySep 22, 2016Leak/Splash; Material Rupture; Material Separation; Leak/Splash; Material Rupture; Material Separation

  IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE UNDERWENT A FENESTRATED ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE. A TYPE 3 ENDOLEAK WAS OBSERVED AND THOUGHT TO BE CAUSED BY A GRAFT TEAR. AFTER DEPLOYMENT OF THE DEVICE WITH A 2.2 CM OF OVERLAP INSIDE THE CONTRALATERAL GATE OF THE DEVICE AND ALMOST 3CM PLUS OVERLAP INSIDE OF ANOTHER MANUFACTURER'S SELF-EXPANDING STENT. THE COMPETITOR'S DEVICE WAS BALLOONED WITH THE 7MM X 40MM ANGIOPLASTY BALLOON. THE BALLOON CATHETER WAS THEN USED TO BALLOON MOLD THE PROXIMAL OVERLAP (INSIDE THE DEVICE'S DISTAL BODY) AND THE DISTAL OVERLAP SEGMENT (INSIDE THE COMPETITOR'S DEVICE). A FINAL ANGIOGRAM REVEALED CONTRAST COMING OUTSIDE OF THE TWO STENT GRAFTS (9X107 AND 8X10CM) PRECISELY AT THE MOST PROXIMAL LEVEL OF THE COMPETITOR'S DEVICE WHERE THE DEVICE BEGAN ITS OVERLAP. THE PHYSICIANS BELIEVED THAT THE LEAK WAS THE RESULT OF A TYPE 3 ENDOLEAK CAUSED BY A GRAFT TEAR. THEREFORE, THE DECISION WAS MADE TO USE A 10X5CM COMPETITOR'S DEVICE IN HOPES THAT THIS WOULD RESOLVE THE LEAK. THE 10X5CM STENT GRAFT WAS DEPLOYED. HOWEVER, THE LEAK REMAINED. THE PHYSICIAN DECIDED TO USE ANOTHER 9X107 DEVICE TO RE-ALIGN THE FIRST 9X107 DEVICE. INTRODUCTION A

  Patient problems: No Code Available

  MAUDE report 5970149 ↗