Renegade™ HI-FLO™ Kit M001182980Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729280736), received between Oct 5, 2018 and Oct 5, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2018Break; Break

  IT WAS REPORTED THAT THE DEVICE SNAPPED. A RENEGADE HI FLOW 105/10 KIT WAS SELECTED FOR USE. DURING PREPARATION, THE CARRIER TUBE WAS HYDRATED BEFORE REMOVING THE DEVICE. WHEN IT WAS PULLED OUT OF THE LOOP, IT WAS FOUND OUT THAT THE CATHETER HAD BEEN SNAPPED AND COULD SEE THE BRAIDING INSIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RENEGADE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE HUB, SHAFT AND TIP WERE MICROSCOPICALLY EXAMINED. THE DEVICE WAS FRACTURED IN 1 LOCATION. THE LOCATION OF THE FRACTURE WAS 4CM FROM THE HUB. THE SHAFT WAS NOT COMPLETELY SEPARATED THE INNER LINER WAS STILL CONNECTED. THE STRETCHING AND THE FRACTURES THAT WERE NOTICED ON THE DEVICE ARE CONSISTENT WITH THE DEVICE BEING REMOVED FROM THE SHIPPING TUBE WITHOUT BEING COMPLETELY HYDRATED WITH SALINE. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.

  Patient problems: No Patient Involvement

  MAUDE report 7938922 ↗