Zenith Renu G55376Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002553764), received between Dec 12, 2019 and Sep 1, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Complete Blockage” (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.

• InjurySep 1, 2020Off-Label Use; Patient-Device Incompatibility; Off-Label Use; Patient-Device Incompatibility

  IN ADDITIONAL INFORMATION RECEIVED ON 08SEP2020, 09SEP2020, AND 10SEP2020, IT WAS REPORTED THAT THE "DELIVERY SYSTEM WAS TOO BIG FOR NATIVE ILIACS". IT WAS ALSO REPORTED THAT THE STENT WAS ABLE TO BE DELIVERED TO ITS INTENDED LOCATION. AS THE PHYSICIAN ATTEMPTED TO RETRIEVE THE TOP CAP, THE GRAY DILATOR WAS UNABLE TO PASS THE COMMON ILIAC ARTERY (CIA) AND WHEN ATTEMPTING TO PUSH HARDER, THE LIMB DISLODGED FROM ITS INTENDED LANDING ZONE IN THE CIA (AS IT WAS BEING PUSHED "BACK UP INTO THE SAC"). THE PHYSICIAN THEN PROCEEDED TO TRY AND PULL THE TOP CAP BACK INTO THE DELIVERY SYSTEM; HOWEVER, IT WAS CATCHING THE "BARE CROWN STENT. THE PHYSICIAN DECIDED AT THAT POINT TO CONVERT TO AN OPEN PROCEDURE AND EXPLANT THE COOK GRAFT. THE OPEN PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS SENT TO RECOVERY. THE PATIENT REPORTEDLY DID QUITE WELL POST PROCEDURE BUT UNFORTUNATELY, DUE TO UNFORESEEN CIRCUMSTANCES, PASSED AWAY A WEEK LATER. THE CAUSE OF DEATH WAS NOT REPORTED AND IT IS UNKNOWN IF THE PATIENT'S DEATH WAS RELATED TO THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 10480051 ↗
• InjuryDec 12, 2019Complete Blockage; Complete Blockage

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

  Patient problems: No Code Available

  MAUDE report 9458317 ↗