Zenith Spiral-Z G55229Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002552293), received between Sep 26, 2017 and Jun 10, 2024 — classified as 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 19499301 ↗
• MalfunctionFeb 17, 2021Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS PROVIDED ON 29MAR2021. IT WAS REPORTED THAT "THE PRODUCT SPECIALIST EMPHASIZES THAT THE REPORT IS FOR THE BRANCH ZSLE-11-122 LOT 13204363 OF WHICH THE LEAK IS SUSPECTED". THE SALES REPRESENTATIVE WAS PRESENT FOR THE PROCEDURE. THE PATIENT SUFFERED "LEAKAGE IN A RUPTURED AORTA". REGARDING PATIENT OUTCOME, IT WAS REPORTED THAT "IT WAS REQUESTED TO REVERSE" AND THAT THE PATIENT WAS TAKEN TO THE ICU AND IS STILL CURRENTLY ALIVE. NECK SHAPE ANATOMY WAS DESCRIBED AS "RIGHT". A MANUAL SYRINGE WAS USED TO INFLATE THE BALLOON TO A VOLUME OF 30 CC, "WHAT THE DOCTOR WOULD FEEL AT THE FLAT". IT WAS STATED THAT "THE POROSITY OF THE FABRIC APPEARS TO BE FROM THE LEFT SIDE BRANCH".

  Patient problems: Aneurysm

  MAUDE report 11339493 ↗
• InjuryDec 19, 2017Occlusion Within Device; Occlusion Within Device

  THE USER FACILITY REPORTED A MALE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2017. AS REPORTED, THE PATIENT WAS IMPLANTED WITH A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY GRAFT AND TWO ZENITH¿ SPIRAL-Z¿ AAA ILIAC LEGS; A CONTRALATERAL LEG (ZSLE-11-122-ZT) AND AN IPSILATERAL LEG (ZSLE-16-56-ZT) WITH NO PROBLEMS OCCURRING. ON (B)(6) 2017, THE PATIENT COMPLAINED OF COLDNESS OF THE LOWER LEGS, SO AN ANKLE BRACHIAL INDEX (ABI) TEST WAS PERFORMED. THE ABI LEVEL READING WAS 0.4. THE LEVEL RIGHT AFTER THE EVAR WAS 1.0. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND FOUND CLOTS INSIDE THE CONTRALATERAL LEG GRAFT (ZSLE-11-122-ZT) NEAR THE BIFURCATION OF THE EXTERNAL ILIAC ARTERY AND THE INTERNAL ILIAC ARTERY. BECAUSE OF STENOSIS DUE TO THE CLOTS, THE PHYSICIAN PLANNED REMOVAL OF THE CLOTS AND ENDOVENOUS LASER TREATMENT (EVT) THE NEXT DAY, AND ADMINISTERED ONE TABLET OF PLAVIX (ANTIPLATELET DRUG). ON (B)(6) 2017, THE ABI LEVEL HAD INCREASED TO 0.8 BEFORE PERFORMING ANGIOGRAPHY, THE CLOTS APPEARED TO BE DISSOLVED ON THE ANGIOGRAPHIC IMAGE, AND THE PERCENTAGE OF STENOSIS WAS 70%. DUE TO THIS IMPROVEMENT TENDENC

  Patient problems: No Code Available; Stenosis; Thrombus

  MAUDE report 7128114 ↗
• InjurySep 26, 2017Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  THE AREA REPRESENTATIVE REPORTED DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) CASE, WHILE USING THE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG AN ENDOLEAK OCCURRED. AS REPORTED, IT WAS SUSPECTED THERE WAS A HOLE IN THE GRAFT. WALL STENTS WERE THEN USED TO RELINE THE REPAIR BUT THE ENDOLEAK REMAINED. THE SURGEONS THEN RELINED WITH A COVERED GRAFT AND THE ENDOLEAK RESOLVED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. FURTHER PATIENT AND EVENT DETAILS ARE ANTICIPATED.

  Patient problems: No Code Available

  MAUDE report 6895265 ↗