Zenith Spiral-Z G55225Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002552255), received between Nov 21, 2018 and Jul 23, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: Clinical Endoleak

  MAUDE report 19808711 ↗
• InjuryJun 10, 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: Ischemia; Thrombosis/Thrombus

  MAUDE report 19499501 ↗
• MalfunctionNov 21, 2018Leak/Splash; Leak/Splash

  IT WAS INITIALLY REPORTED THAT A CLINICAL STUDY PATIENT HAS EXPERIENCED A DISTAL TYPE I ENDOLEAK. ACCORDING TO THE REPORT, THE PRE-PROCEDURE CT SCAN SHOWED A CONTAINED RUPTURED TYPE IV ANEURYSM. THE CELIAC ARTERY, SMA AND BOTH RENAL ARTERIES WERE PATENT, WITH NO EVIDENCE OF RENAL INFARCTS. ON (B)(6) 2017, THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE (EVAR). THERE WERE NO KNOWN DIFFICULTIES WITH DEPLOYMENT. RESULTS OF THE PROCEDURAL ANGIOGRAM PERFORMED AT THE CONCLUSION OF THE PROCEDURE REVEALED PATENT GRAFTS WITH NO ENDOLEAK OR DEVICE INTEGRITY ISSUES. THE FOLLOWING ADDITIONAL PROCEDURE WAS PERFORMED, PER COMMENTS FROM THE SITE: ¿ON THE (B)(6) THE PROSTHESIS FOR THE LEFT SIDE TO PREVENT SPINAL ISCHEMIA. A ZSLE 13-107 AND A STENT FROM ANOTHER MANUFACTURER WERE IMPLANTED TO RELINE THE IMPLANTED GRAFTS. ON (B)(6) 2017 (20 DAYS POST-PROCEDURE), A FOLLOW-UP CT SCAN SHOWED THAT THE DEVICES WERE PATENT, AND THE STENTED CELIAC ARTERY, SMA, AND BILATERAL RENAL ARTERIES WERE PATENT. A TYPE III ENDOLEAK WAS NOTED BY THE SITE, WITH THE FOLLOWING STATEMENT: ¿THE LEFT ILIAC GRAFT (NON-COOK DEVICE) WAS NOT IMPLANTED IN THE FIRST INTERVENTION. IT WAS LEFT FOR PERFUSION OF THE AN

  Patient problems: No Code Available

  MAUDE report 8096977 ↗