Zenith Flex G48412Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10827002484129), received between Mar 24, 2015 and Jun 1, 2023 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2023Migration; Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17040324 ↗
• MalfunctionJul 17, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING AN ABDOMINAL AORTIC ANEURYSM REPAIR WHILE USING THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, THAT THE BLUE TRIGGER WIRE MECHANISM BECAME UNBONDED FROM THE TRIGGER WIRE. THE PHYSICIAN WAS ABLE TO GRAB THE WIRE AND REMOVE IT MANUALLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. IT WAS FURTHER EXPLAINED THAT TO RELEASE THE TRIGGER-WIRE THE BLACK THUMB SCREW WAS REMOVED. AFTER THAT, THEY SLID THE MECHANISM BACK OFF THE DEVICE AND COULD SEE THE WIRE ORIGINALLY. THEY PUT DOWN THE BLUE MECHANISM AND WENT TO LOOSEN PIN VICE. WHEN THEY WERE HAVING DIFFICULTIES IN DEPLOYMENT, IT WAS NOTICED THAT THE MECHANISM WAS UNBONDED. IT WAS NOTED THAT THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE BEFORE USE AND THERE WAS NO SIGNIFICANT RESISTANCE NOTICED WHEN REMOVING THE TRIGGER WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7694534 ↗
• MalfunctionJul 20, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THIS IS A DUPLICATE REPORT OF AN EVENT THAT WAS PREVIOUSLY SUBMITTED IN A REPORT WITH REPORT NUMBER 1820334-2016-00974.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6728298 ↗
• MalfunctionJul 18, 2017Material Puncture/Hole

  PRIOR TO PATIENT USE, THE STENT MAIN BODY WAS BEING PLACED ON THE WIRE, AT THAT TIME THE WIRE PUNCTURED THROUGH THE DISTAL TIP OF THE DILATOR. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 6723181 ↗
• MalfunctionJul 12, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO PATIENT CONTACT, THE USER EXPERIENCED FLUSHING DIFFICULTY OF THE DELIVERY SYSTEM DUE TO SALINE LEAK FROM THE HEMOSTATIC VALVE. HE TURNED THE VALVE ROTATOR TO 'CLOSE' AND FLUSHED SEVERAL TIMES, BUT SALINE WOULD NOT COME OUT OF THE PORT. HE REPLACED IT WITH A BACK-UP (TFB-26-74-ZT / (B)(4)) AND COULD FLUSH THE REPLACEMENT TO USE WITH NO PROBLEM. THERE WERE NO REPORTED CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708587 ↗
• InjuryOct 6, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED A FEMALE PATIENT HAD ENDOVASCULAR ANEURYSM REPAIR (EVAR). AFTER THREE GRAFTS WERE PLACED, THE PHYSICIAN CONFIRMED PROXIMAL TYPE I ENDOLEAK AND TYPE IV ENDOLEAK FROM ALL 3 STENT GRAFTS THROUGH ANGIOGRAPHY. THE PROXIMAL TYPE I ENDOLEAK WAS GONE AFTER ADDITIONAL BALLOONING AT THE PROXIMAL NECK, ATTEMPTS TO SOLVE THE TYPE IV ENDOLEAK WITH FURTHER PLACEMENT WERE UNSUCCESSFUL. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH AND COMPLETED THE PROCEDURE. THE PATIENT HAS NOT SHOWN ANY PROBLEMATIC SYMPTOMS.

  Patient problems: Aneurysm

  MAUDE report 6003260 ↗
• InjurySep 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM (AAA REPAIR) IN (B)(6) 2016. A TYPE IV ENDOLEAK FROM THE MAIN BODY AND LEGS WAS CONFIRMED AFTER PLACING ALL THE STENT GRAFTS. THE USER STATED THAT IT WAS A LARGE TYPE IV ENDOLEAK. THE PHYSICIAN TOOK A WAIT AND SEE APPROACH. AT THE FOLLOW UP EXAM IT WAS CONFIRMED THAT THE ENDOLEAK WAS GONE. THE PATIENT'S CONDITION IS UNKNOWN AS IT WAS NOT PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5970065 ↗
• InjurySep 16, 2016Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem

  DURING PLACEMENT OF A MAIN BODY GRAFT IN AN ABDOMINAL AORTIC ANEURYSM, THE SUPRARENAL STENT WAS CLOSED IN THE TOP CAP AND IT WAS IMPOSSIBLE TO OPEN IT ADVANCING WITH INNER CANNULA. AFTER DEPLOYING THE GRAFT, THE SECOND TRIGGER WAS REMOVED AND THE GRAFT WAS STABILIZED WITH A BALLOON. THE SUPRARENAL STENT WAS OPENED BY ADVANCING WITH THE INNER CANNULA AND GREY POSITIONER. THE PROCEDURE WAS PROLONGED DUE TO THE OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5956913 ↗
• InjuryMar 24, 2015Leak/Splash

  A EVAR WAS BEING PERFORMED ON (B)(6) PATIENT. THE CASE WAS PERFORMED ACCORDING TO IFU WITH THE EXCEPTION OF THE TOP CAP DEPLOYMENT. IN THIS CASE THE TOP CAP WAS RELEASED AND DEPLOYED PRIOR TO CONTRALATERAL GATE CANNULATION. THE MAIN BODY WAS PLACED JUST BELOW THE LOWEST RENAL ARTERY. THE LEG GRAFT WAS THE CONTRALATERAL LIMB AND LANDED WITHIN THE LEFT COMMON ILIAC. THE SECOND LEG GRAFT WAS THE IPSILATERAL LIMB AND LANDED WITHIN THE RIGHT COMMON. ALL SEAL ZONES AND OVERLAPS WERE BALLOONED USING A 32MM CODA BALLOON. UPON FINAL RUN AN ENDOLEAK WAS NOTICED. HE DID RETROGRADE INJECTIONS ON BOTH LIMBS SEPARATELY TO SEE IF THE LEAK WAS FROM A TYPE 2 BUT COULD NOT CONFIRM. THE SURGEON THEN PERFORMED AN OBLIQUE VIEW AND DID ANOTHER RUN. HE VISUALIZED A LEAK FROM WHAT HE THOUGHT WAS A TYPE 3 FROM THE CONTRALATERAL LIMB. UPON REVIEW OF THE CT HE NOTICED THERE WAS SOME CALCIUM AT THE AORTIC BIFURCATION. ANOTHER GRAFT WAS PLACED ACROSS THE AREA OF CONCERN AND RE-BALLOONED AT THE PROXIMAL AND DISTAL SEALING AREAS. ANOTHER ANGIO WAS PERFORMED WHICH STILL SHOWED AN ENDOLEAK. MULTIPLE VIEWS WERE PERFORMED INCLUDING SHOOTING RUNS WITH A BALLOON IN EACH LIMB. THE SURGEON STILL FELT THERE WAS A TYPE 3

  Patient problems: Surgical procedure, additional

  MAUDE report 4640419 ↗