Zenith Spiral-Z G55221Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002552217), received between Apr 7, 2016 and Jun 25, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Obstruction 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: Thrombosis/Thrombus

  MAUDE report 19605541 ↗
• InjuryApr 13, 2023Obstruction of Flow; Obstruction of Flow

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

  Patient problems: Obstruction/Occlusion

  MAUDE report 16736955 ↗
• 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 EXTERNAL 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 AO

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

  MAUDE report 13538750 ↗
• InjuryDec 14, 2018Obstruction of Flow; Obstruction of Flow

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 8166866 ↗
• MalfunctionApr 7, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  DURING A PROCEDURE ON A (B)(6) MALE PATIENT, THE MAINBODY WAS PLACED INITIALLY. THEN THE 9 MM X 90 MM ENDOVASCULAR ILIAC LEG GRAFT WAS PLACED BUT IT WAS TOO SHORT. AFTER THE PROCEDURE, THE PHYSICIAN MEASURED THE LEG GRAFT VIA X-RAY AND THE GRAFT MEASURED A 9 MM X 74 MM LONG LEG INSTEAD. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE IMPLANTED LEG GRAFT IS SHORT, BUT THE PATIENT IS REPORTED TO BE DOING FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5553748 ↗