Zenith Flex G48453Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002484532), received between Apr 17, 2020 and Jul 6, 2021 — classified as 1 injury, 1 malfunction.

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

• InjuryJul 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  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 12120557 ↗
• MalfunctionApr 17, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE PATIENT'S "TUMOR NECK" WAS SHORT SO IT WAS PLANNED TO PRE-FENESTRATE THE TFFB-32-111-ZT FOR THE RENAL ARTERIES AND MESENTERIC ARTERY. USING AN ILIAC BRANCHED DEVICE, THE PLAN WAS TO BLOCK THE RIGHT INTERNAL ILIAC AND KEEP THE LEFT INTERNAL ILIAC OPEN. FIRST, THE RIGHT INTERNAL ILIAC WAS BLOCKED WITH INTERLOCK. THE RIGHT ILIAC STENT TFLE-12-124-ZT WAS IMPLANTED, THEN THE FIRST AND SECOND LEFT ILIAC STENTS WERE IMPLANTED AND CONTRAST MEDIUM WAS INJECTED AT THE LEFT ILIAC ARTERY. CONTRAST MEDIUM WAS NOTED TO BE LEAKING ON IMAGING AT THE SECOND LEFT INTERNAL ILIAC STENT AND THE RIGHT ILIAC STENT TFLE-12-124-ZT. BALLOONING WAS PERFORMED AT THE OVERLAP OF THE RIGHT ILIAC AND MAIN STENT BRANCH AND THE OVERLAP OF THE RIGHT ILIAC STENT AND RIGHT EXTERNAL ILIAC. CONTRAST MEDIUM WAS STILL NOTED TO BE LEAKED AFTER THE SECOND RIGHT ILIAC STENT TFLE-12-90-ZT WAS IMPLANTED. AFTER THE THIRD RIGHT ILIAC STENT TFLE-12-73-ZT WAS IMPLANTED, LEAKING WAS REDUCED BUT STILL OBSERVED. THE PATIENT HAD A FEVER THE FIRST DAY AFTER THE PROCEDURE BUT RECOVERED THE SECOND DAY. THE PATIENT HAS SINCE BEEN DISCHARGED. THERE WERE NO ADDITIONAL PROCEDURES. THE SALES REPRESENTATIVE WAS PRESENT FOR THE CASE. THE ON

  Patient problems: Fever; No Consequences Or Impact To Patient

  MAUDE report 9974006 ↗