Zenith Flex G48419Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10827002484198), received between Apr 1, 2015 and Sep 13, 2024 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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.

• MalfunctionSep 13, 2024Fluid/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: Clinical Endoleak

  MAUDE report 20214934 ↗
• MalfunctionMay 10, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED TO COOK ON 13MAY2024 THAT THE DIFFICULT ADVANCEMENT OVER THE LUNDERQUIST WIRE HAPPENED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED OVER THE AMPLATZ WIRE IN THE SAME WAY IT WOULD HAVE OVER A LUNDERQUIST WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287934 ↗
• MalfunctionMay 31, 2019Activation Problem; Activation Problem

  IT WAS REPORTED THE CUSTOMER DEPLOYED THE ENDOGRAFT CORRECTLY AND TOOK AWAY THE FIRST TRIGGER WIRE. THE PROBLEM APPEARED WHEN THEY TRIED TO PUSH THE NOSE AFTER UNSCREWING THE PIN VISE. THE SURGEON WAS NOT ABLE TO PUSH THE NOSE OF THE DILATOR TO DEPLOY THE BARE STENT. THE SURGEON PERFORMED THE TROUBLESHOOTING FOR THIS ISSUE THAT IS FOUND IN THE IFU AND IT SOLVED THE ISSUE. THE PATIENT WAS NOT INJURED AND FINAL IMAGING WITH FLUOROSCOPY AND CONTRAST LIQUID WAS PERFECT. ADDITIONAL INFORMATION REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. THIS REPORT CONTAINS ALL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8658087 ↗
• InjuryMay 1, 2019Activation Problem; Activation Problem

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 8570181 ↗
• InjuryMar 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO NEW EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 8465122 ↗
• InjuryDec 31, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 8206183 ↗
• InjuryDec 3, 2018Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow

  DURING THE EXPLANT PROTOCOL, IT WAS IDENTIFIED THAT THROMBUS WAS PRESENT IN THE MAIN BODY.

  Patient problems: No Code Available

  MAUDE report 8125043 ↗
• InjuryAug 1, 2018Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  THE SITE INDICATED THAT THE PATIENT WOULD BE TREATED IN SEPTEMBER. AS OF 08OCT2018, NO PATIENT TREATMENT HAS BEEN REPORTED.

  Patient problems: Clinical Endoleak; No Consequences Or Impact To Patient

  MAUDE report 7739657 ↗
• InjuryApr 1, 2015Fluid/Blood Leak

  DURING AN AAA PROCEDURE ON A MALE PATIENT, THE VALVE WAS NOT SEALED AND APPROXIMATELY 1 L OF BLOOD WAS FOUND ON THE OPERATIVE FIELD. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: Blood Loss

  MAUDE report 4662290 ↗