GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet 5393500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741012235), received between May 18, 2018 and Sep 8, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Flush” (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 18, 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.

• MalfunctionSep 8, 2020Difficult to Flush; Obstruction of Flow; Difficult to Flush; Obstruction of Flow

  IT WAS REPORTED THAT AFTER DIALYSIS CATHETER PLACEMENT, THE DEVICE WAS ALLEGEDLY UNABLE TO BE FLUSHED. IT WAS FURTHER REPORTED THAT, THE DEVICE WAS REMOVED FROM THE PATIENT AND STILL UNABLE TO FLUSH THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10501052 ↗
• MalfunctionMay 18, 2018Kinked; Kinked

  IT WAS REPORTED THAT THE CLAMP IS CRIMPING DOWN ON THE END, IMPEDING FLOW. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7527422 ↗