GLIDESHEATH SLENDER RM*ES5F10HAURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987350722645), received between Apr 13, 2018 and Apr 13, 2018 — classified as 1 injury.

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

• InjuryApr 13, 2018Break; Break

  THE USER FACILITY REPORTED THAT THE PHYSICIAN USED AN 6FR SLENDER A-KIT TO GAINED ACCESS UTILIZING THE ANGIOCATH NEEDLE. UPON REMOVING THE NEEDLE THE PHYSICIAN STATED THAT THE HUB OF THE ANGIOCATH CAME OUT, LEAVING THE PLASTIC JACKET IN THE ARTERY. THEY WERE UNABLE TO RETRIEVE AND THE PATIENT HAD TO BE REFERRED TO VASCULAR SURGERY. IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED AS PATIENT HAD TO BE REFERRED TO SURGERY. THE PATIENT WAS REPORTED TO BE OK. ADDITIONAL INFORMATION WAS RECEIVED ON 3/22/2019. THE PLASTIC JACKET BROKE OFF THE ANGIOCATH NEEDLE, NOT THE SHEATH, IN THE PATIENTS ARTERY. THE PATIENT HAD TO GO TO VASCULAR SURGERY TO HAVE THE PLASTIC JACKET REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7430427 ↗