GLIDECATH CG412Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04987350772138), received between Jun 7, 2017 and May 15, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2025Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE 4FR GLIDECATH WAS PLACED UP AND OVER THE AORTIC BIFURCATION CONTRALATERALLY FROM THE LEFT SIDE. WHILE PULLING THE CATHETER BACK ACROSS THE BIFURCATION THE CATHETER TORE WITH APPROXIMATELY 30% OF THE CATHETER LODGING ITSELF IN THE RIGHT COMMON ILIAC. THE RIGHT GROIN WAS ACCESSED, AND THE BROKEN PIECE OF CATHETER WAS SNARED AND SAFELY REMOVED. THE PHYSICIAN STATED THAT THE PATIENTS' VESSELS WERE CALCIFIED. THE WERE NO BLOOD LOSS. THE PATIENT CONDITION WAS STABLE. THE PROCEDURE WAS AN AORTA BILATERAL FEMORAL ANGIOGRAM. ADDITIONAL INFORMATION WAS RECEIVED ON 18APR2025: THE DOCTOR BELIEVED THE PATIENTS CALCIFICATION HAD SOMETHING TO DO WITH THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22024886 ↗
• InjuryMay 15, 2025Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE 4FR GLIDECATH WAS PLACED UP AND OVER THE AORTIC BIFURCATION CONTRALATERALLY FROM THE LEFT SIDE. WHILE PULLING THE CATHETER BACK ACROSS THE BIFURCATION THE CATHETER TORE WITH APPROXIMATELY 30% OF THE CATHETER LODGING ITSELF IN THE RIGHT COMMON ILIAC. THE RIGHT GROIN WAS ACCESSED, AND THE BROKEN PIECE OF CATHETER WAS SNARED AND SAFELY REMOVED. THE PHYSICIAN STATED THAT THE PATIENTS' VESSELS WERE CALCIFIED. THE WERE NO BLOOD LOSS. THE PATIENT CONDITION WAS STABLE. THE PROCEDURE WAS AN AORTA BILATERAL FEMORAL ANGIOGRAM. ADDITIONAL INFORMATION WAS RECEIVED ON 18APR2025: THE DOCTOR BELIEVED THE PATIENTS CALCIFICATION HAD SOMETHING TO DO WITH THE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22023932 ↗
• MalfunctionApr 29, 2024

  ELDERLY MALE WITH HISTORY OF PERIPHERAL ARTERIAL DISEASE AND RECENT GANGRENE OF BILATERAL LOWER EXTREMITIES. PROCEDURE: AORTOGRAM AND ANGIOPLASTY OF THE LEFT COMMON ILIAC ARTERY AND EXTERNAL ILIAC ARTERY WITH A 6 MM X 100 MM DRUG-COATED BALLOON, AND ANGIOPLASTY OF THE COMMON FEMORAL ARTERY AND SUPERFICIAL FEMORAL ARTERY WITH A 6 MM X 6 CM DRUG-COATED BALLOON AND MYNX. CATHETER BROKE INTO 2 PIECES INSIDE THE PATIENT. SURGEON SUCCESSFULLY RETRIEVED BOTH PIECES WITHOUT KNOWN INJURY. PATIENT DISCHARGED THE SAME DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19201354 ↗
• InjuryApr 4, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDECATH DEVICE INVOLVED SHEARED OFF INSIDE THE PATIENT DUE TO SEVERE CALCIUM DEPOSITS. THE PIECE WAS RETRIEVED WITH A SNARE AND THE PATIENT WAS UNAFFECTED. THERE PATIENT CONDITION WAS FINE. THE PROCEDURE OUTCOME WAS FINE. THERE WAS NO PATIENT INJURY/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 29 MAR 2022: THE PROCEDURE PERFORMED WAS A THROMBOENDOARTERECTOMY FEMORAL ARTERY AND ABD AORTOGRAPHY.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 13998719 ↗
• InjuryApr 4, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDECATH DEVICE INVOLVED SHEARED OFF INSIDE THE PATIENT DUE TO SEVERE CALCIUM DEPOSITS. THE PIECE WAS RETRIEVED WITH A SNARE AND THE PATIENT WAS UNAFFECTED. THERE PATIENT CONDITION WAS FINE. THE PROCEDURE OUTCOME WAS FINE. THERE WAS NO PATIENT INJURY/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 29 MAR 2022: THE PROCEDURE PERFORMED WAS A THROMBOENDOARTERECTOMY FEMORAL ARTERY AND ABD AORTOGRAPHY.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 13998495 ↗
• InjuryJul 18, 2018Material Separation; Material Separation

  THE USER FACILITY REPORTED THE GLIDECATH WAS INSERTED THROUGH 6 FR PINNACLE R/O OVER AMPLATZ WIRE. WHEN IT WAS REMOVED, THE TECH NOTICED THAT THE END OF THE CATHETER LOOKED DIFFERENT THAN NORMAL. IT WAS QUICKLY REALIZED THAT A DISTAL PART OF THE CATHETER HAD BROKEN OFF. THE END OF THE CATHETER WAS EASILY RETRIEVED WITH AN ENSNARE DEVICE. THE PATIENT DID FINE AND THE REST OF THE PROCEDURE CONTINUED AS NORMAL. THE PATIENT WAS UNAFFECTED AND DID FINE. THE PROCEDURE OUTCOME WAS REPORTED TO BE A SUCCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7698183 ↗
• MalfunctionJun 7, 2017Break; Break

  THE USER FACILITY REPORTED BREAKAGE WITH THE INVOLVED GLIDECATH DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THEY USED THE CATHETER TO CROSS THE BIFURCATION AND WHEN THEY WERE TRYING TO REMOVE IT OVER THE WIRE, IT GOT STUCK ON THE WIRE AND SNAPPED IN HALF; THE PROCEDURE WAS COMPLETED; AND THE PATIENT WAS REPORTED TO BE IN NORMAL CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 1, 2017. THE CATHETER WAS ABLE TO BE REMOVED COMPLETELY. THE PATIENT WAS REPORTED TO BE STABLE. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6618624 ↗