Cook G52835Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002528352), received between Sep 26, 2022 and Feb 2, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2026Inadequacy of Device Shape and/or Size

  ADDITIONAL INFORMATION WAS PROVIDED ON 20JAN2026. THE STENOSIS OF THE RIGHT ILIAC ARTERY WAS NOT RELATED TO THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. THE PRINCIPAL INVESTIGATOR CONFIRMED THAT NONE OF THE COOK IMPLANTED DEVICES WERE PLACED OR PASSED THROUGH THE RIGHT EXTERNAL ILIAC ARTERY. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2026.

  Patient problems: Vascular Dissection

  MAUDE report 24240550 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT STOPPED MOVING HER LEGS AND REQUIRED A TOTAL COLECTOMY THE DAY AFTER AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE FOR THE PROXIMAL AORTIC ARCH WAS COMPLETED. THE 67 YEAR-OLD FEMALE PATIENT UNDERWENT SEVERAL PROCEDURES ON (B)(6) 2022. FIRST A SPINAL DRAIN AS WELL AS A LEFT SUBCLAVIAN CORONARY ARTERY (LSCA) BYPASS WERE COMPLETED PRIOR TO THE EVAR PROCEDURE. THE PHYSICIAN ANTICIPATED ISSUES WITH FEMORAL ACCESS AND TIGHT AORTIC BIFURCATION PRIOR TO THE EVAR PROCEDURE. INITIAL ACCESS WAS ESTABLISHED USING GRADUATING DILATOR TRANSITIONS AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOONING PRIOR TO ADVANCING THE 18 FRENCH DELIVERY SYSTEM AND THE COOK CHECK-FLO EXTRA LARGE INTRODUCER (20FRENCH, 40CM SHEATH). INITIALLY THE FENESTRATED COMPONENT WAS PLANNED TO BE ADVANCED UP THE RIGHT HAND SIDE (RHS), THIS WAS SWITCHED TO THE LEFT HAND SIDE (LHS) AFTER THE COOK CHECK-FLO EXTRA LARGE INTRODUCER (20FRENCH, 40CM SHEATH) WOULD NOT TRACK UP THE LHS. COOK GRAFTS IMPLANTED INCLUDED: ZENITH FENESTRATED GRAFT, RPN: FEN-THORACO-ABDOMINAL-GRAFT. ZENITH GRAFT, RPN: PROXIMAL-THORACIC. ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS, RPN: ZTA-P-30-201. Z

  Patient problems: Paralysis; Unspecified Vascular Problem

  MAUDE report 15486921 ↗