GLIDECATH CG417Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04987350772237), received between Apr 4, 2023 and Nov 27, 2024 — classified as 4 injuries.

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

• InjuryNov 27, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THE CATHETER SHEARED OFF WHILE IN USE, THEY WERE ABLE TO RETRIEVE ALL PIECES AND CASES WAS ABORTED. THE PROCEDURE TYPE WAS PERIPHERAL ARTERIAL DISEASE (PAD). THE PATIENT'S CONDITION WAS NOT APPLICABLE. NO RELEVANT TESTS WERE CONDUCTED. THERE WAS NO BLOOD LOSS. THERE WAS NO INJURY DESCRIBED, AND THERE WAS NO DIRECT ALLEGATION. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 14 NOV 2024: THE SAMPLE IS NOT CONTAMINATED BY ANTI-CANCER AGENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20803223 ↗
• InjuryNov 27, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THE CATHETER SHEARED OFF WHILE IN USE, THEY WERE ABLE TO RETRIEVE ALL PIECES AND CASES WAS ABORTED. THE PROCEDURE TYPE WAS PERIPHERAL ARTERIAL DISEASE (PAD). THE PATIENT'S CONDITION WAS NOT APPLICABLE. NO RELEVANT TESTS WERE CONDUCTED. THERE WAS NO BLOOD LOSS. THERE WAS NO INJURY DESCRIBED, AND THERE WAS NO DIRECT ALLEGATION. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEVIED ON 14 NOV 2024: THE SAMPLE IS NOT CONTAMINATED BY ANTI-CANCER AGENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20803222 ↗
• InjuryNov 28, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE PROCEDURE PERFORMED WAS A PARAVALVULAR AORTIC LEAK. THE PHYSICIAN ATTEMPTED TO CANULATE THE LEAK WITH THE GLIDE CATHETER INVOLVED. IT WAS NOTED DURING THE PROCEDURE THE GLIDE CATHETER FELT SNUG/TIGHT INSIDE THE LEAK. THE PHYSICIAN ATTEMPTED TO REMOVE THE GLIDE CATHETER AND HAD TO PULL WITH MORE FORCE THAN USUAL. IT WAS NOTED THE TIP HAD BROKEN OFF AND WAS LEFT IN THE LEAK. A SNARE WAS INSERTED AND REMOVED THE BROKEN TIP SAFELY. NO HARM TO THE PATIENT AND THE PROCEDURE WAS ABLE TO BE COMPLETED. THE PATIENT WAS IN STABLE CONDITION. THE PARAVALVULAR PLUG PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 21 MAR 2023: AN ANGIOGRAPHY WAS USED TO DETERMINE THAT THE ENTIRE BROKEN TIP WAS SAFELY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220961 ↗
• InjuryApr 4, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE PROCEDURE PERFORMED WAS A PARAVALVULAR AORTIC LEAK. THE PHYSICIAN ATTEMPTED TO CANULATE THE LEAK WITH THE GLIDE CATHETER INVOLVED. IT WAS NOTED DURING THE PROCEDURE THE GLIDE CATHETER FELT SNUG/TIGHT INSIDE THE LEAK. THE PHYSICIAN ATTEMPTED TO REMOVE THE GLIDE CATHETER AND HAD TO PULL WITH MORE FORCE THAN USUAL. IT WAS NOTED THE TIP HAD BROKEN OFF AND WAS LEFT IN THE LEAK. A SNARE WAS INSERTED AND REMOVED THE BROKEN TIP SAFELY. NO HARM TO THE PATIENT AND THE PROCEDURE WAS ABLE TO BE COMPLETED. THE PATIENT WAS IN STABLE CONDITION. THE PARAVALVULAR PLUG PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 21 MAR 2023: AN ANGIOGRAPHY WAS USED TO DETERMINE THAT THE ENTIRE BROKEN TIP WAS SAFELY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673382 ↗