Renegade™ HI-FLO™ M001182850Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729280606), received between Sep 13, 2019 and May 9, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. How this data works · Data updated Oct 13, 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.

• InjuryMay 9, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A THROMBUS WAS NOTICED. A RENEGADE HI-FLO WAS SELECTED FOR USE IN A MODERATE TO MILDLY TORTUOUS VESSEL. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE DID NOT MOVE SMOOTHLY. WHEN IT WAS USED FOR GASTRO-RENAL SHUNT, IT DID NOT SLIDE WELL AND COULD NOT BE PLACED. THE THROMBUS MIGHT BE CLOGGED INSIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16899397 ↗
• MalfunctionSep 16, 2021Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE GOT SEPARATED WHEN TAKEN OUT. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NONE CALCIFIED RENAL ARTERY. A 105/20 RENEGADE HI-FLO WAS SELECTED FOR USE. DURING PREPARATION, THE BOX WAS OPENED AND THE DEVICE WAS ATTEMPTED TO BE PULLED OUT BY OPENING THE VINYL. IT WAS NOTED THAT IT FELT LIKE THE LOOP (PROTECTIVE TUBE) AND THE DEVICE WERE ADHERED TO EACH OTHER. THE DEVICE ULTIMATELY SEPARATED WHEN TAKEN OUT OF THE PACKAGE AND WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485839 ↗
• MalfunctionJan 26, 2021Stretched; Material Deformation; Physical Resistance/Sticking; Stretched; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT THERE WAS A MILD RESISTANCE WHEN THE DEVICE WAS PULLED OUT. A 105/20 RENEGADE HI-FLO WAS SELECTED FOR USE. THE NON-STENOSED TARGET LESION WAS MODERATELY TORTUOUS AND NON-CALCIFIED. DURING REMOVAL OF THE DEVICE FROM THE PATIENT'S BODY, IT WAS NOTED THAT THERE WAS A MILD RESISTANCE WHEN THE DEVICE WAS PULLED OUT. UPON CHECKING ON THE DEVICE, IT WAS OBSERVED THAT THE TIP WAS STRETCHED AND DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS IN THE HEPATIC ARTERY. THE MICROCATHETER WAS DELIVERED MULTIPLE TIMES. THE MICROCATHETER AND OTHER DEVICES WERE SUFFICIENTLY FLUSHED AND HYDRATED THROUGHOUT THE PROCEDURE. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY WITHOUT ANY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11232592 ↗
• MalfunctionSep 13, 2019Difficult to Open or Remove Packaging Material; Material Integrity Problem; Difficult to Open or Remove Packaging Material; Material Integrity Problem

  REPORTABLE ON ANALYSIS COMPLETED ON 23AUGUST2019. IT WAS REPORTED THAT REMOVAL DIFFICULTIES FROM THE CARRIER TUBE OCCURRED. DURING PREPARATION OF A 105/20 RENEGADE HI-FLO CATHETER, THE CATHETER WAS DIFFICULT TO REMOVE FROM THE CARRIER TUBE. THE CARRIER TUBE WAS FLUSHED AGAIN AND ATTEMPTS TO REMOVE THE CATHETER RESULTED IN STRETCHING THE CATHETER WHEN IT WAS FINALLY RELEASED FROM THE CARRIER TUBE. HOWEVER RETURNED ANALYSIS REVEALED A DETACHED SHAFT.

  Patient problems: No Patient Involvement

  MAUDE report 9035803 ↗