GLIDECATH CG416Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04987350772213), received between Aug 14, 2017 and Nov 5, 2025 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2025Fracture; Fracture

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING AN ANGIOGRAM WITH INTERVENTIONS, THE GLIDECATH BROKE OFF INTO THE PATIENT. THE DOCTOR WAS ABLE TO RECOVER THE BROKEN PIECE FROM THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: THE VESSELS THROUGHOUT THE AORTOILIAC AND FEMORAL-POPLITEAL AREA WERE EXTREMELY ATHEROSCLEROTIC AND DISEASED. THERE WAS A HIGH-GRADE FOCAL STENOSIS IN THE MID RIGHT COMMON ILIAC. THE GLIDECATH BROKE INSIDE THE PATIENT DURING ACCESS. THE BROKEN PIECE WAS RECOVERED. THE DISTAL ILIAC VESSELS WERE PATENT. THE COMMON FEMORAL WAS HEAVILY DISEASED BUT PATENT. THE SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUDED PROXIMALLY WITH DENSE CALCIFIED PLAQUE THROUGHOUT INTO THE ABOVE-KNEE POPLITEAL. THE BELOW-KNEE POPLITEAL WAS PATENT WITH TWO-VESSEL RUNOFF INTO THE FOOT. SURGEON UNABLE TO CROSS THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUSION HOWEVER, THEY DID GET GOOD ANGIOGRAPHIC RESULT AFTER TREATMENT OF THE RIGHT COMMON ILIAC WITH RETURN OF A STRONG RIGHT FEMORAL PULSE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23478049 ↗
• InjuryNov 5, 2025Fracture; Fracture

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING AN ANGIOGRAM WITH INTERVENTIONS, THE GLIDECATH BROKE OFF INTO THE PATIENT. THE DOCTOR WAS ABLE TO RECOVER THE BROKEN PIECE FROM THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 09OCT2025: THE VESSELS THROUGHOUT THE AORTOILIAC AND FEMORAL-POPLITEAL AREA WERE EXTREMELY ATHEROSCLEROTIC AND DISEASED. THERE WAS A HIGH-GRADE FOCAL STENOSIS IN THE MID RIGHT COMMON ILIAC. THE GLIDECATH BROKE INSIDE THE PATIENT DURING ACCESS. THE BROKEN PIECE WAS RECOVERED. THE DISTAL ILIAC VESSELS WERE PATENT. THE COMMON FEMORAL WAS HEAVILY DISEASED BUT PATENT. THE SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUDED PROXIMALLY WITH DENSE CALCIFIED PLAQUE THROUGHOUT INTO THE ABOVE-KNEE POPLITEAL. THE BELOW-KNEE POPLITEAL WAS PATENT WITH TWO-VESSEL RUNOFF INTO THE FOOT. SURGEON UNABLE TO CROSS THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUSION HOWEVER, THEY DID GET GOOD ANGIOGRAPHIC RESULT AFTER TREATMENT OF THE RIGHT COMMON ILIAC WITH RETURN OF A STRONG RIGHT FEMORAL PULSE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 10OCT2025: THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23478045 ↗
• InjuryMar 25, 2025Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS DOING A LEG INTERVENTION AND WAS TRYING TO GET UP AND OVER WITH A LONG 5FR X 45CM SHEATH. THE BIFURCATION WAS VERY STEEP, SO HE ADVANCED A AMPLATZ WIRE OVER AND TOOK DILATOR OUT. HE PUT THE CG416 IN AND TRIED TO ADVANCE DOWN THE CONTRALATERAL SIDE. THERE WAS A LOT OF CALCIFICATIONS ON THE CONTRA ILIAC SIDE AND WHEN HE PULLED THE GLIDECATH BACK IT BROKE OFF IN THE PATIENT. HE SNARED THE PIECE AND THERE WERE NO COMPLICATIONS. THE PATIENT WAS STABLE. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 05MAR2025: TESTING WAS PERFORMED TO VERIFY THE PIECE WAS REMOVED ENTIRELY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21692847 ↗
• InjuryMar 25, 2025Fracture; Fracture

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS DOING A LEG INTERVENTION AND WAS TRYING TO GET UP AND OVER WITH A LONG 5FR X 45CM SHEATH. THE BIFURCATION WAS VERY STEEP, SO HE ADVANCED A AMPLATZ WIRE OVER AND TOOK DILATOR OUT. HE PUT THE CG416 IN AND TRIED TO ADVANCE DOWN THE CONTRALATERAL SIDE. THERE WAS A LOT OF CALCIFICATIONS ON THE CONTRA ILIAC SIDE AND WHEN HE PULLED THE GLIDECATH BACK IT BROKE OFF IN THE PATIENT. HE SNARED THE PIECE AND THERE WERE NO COMPLICATIONS. THE PATIENT WAS STABLE. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 05MAR2025: TESTING WAS PERFORMED TO VERIFY THE PIECE WAS REMOVED ENTIRELY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21692846 ↗
• MalfunctionSep 6, 2022Mechanical Jam; Mechanical Jam

  THE USER FACILITY REPORTED THAT THE COIL ON THE GLIDECATH DEVICE INVOLVED GOT STUCK INSIDE THE CATHETER NEAR THE HUB. THE DEVICE WOULD NOT ALLOW THE COIL TO TRACK OR A WIRE TO PASS. SOMETHING WAS SEEN INSIDE THE CATHETER WHICH CAUSED IT TO JAM (MAYBE SOME OF THE POLYTETRAFLUOROETHYLENE [PTFE] COATING SEPARATED AND JAMMED INSIDE THE CATHETER). THE PATIENT WAS RECOVERING. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 26 MAY 2022: THE PROCEDURE PERFORMED WAS AN ABDOMINAL AORTIC ANEURYSM (AAA) ENDOLEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363089 ↗
• MalfunctionMar 29, 2022Separation Problem; Separation Problem

  THE USER FACILITY REPORTED THAT THE BACK END OF THE GLIDECATH DEVICE INVOLVED BROKE OFF. THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13937661 ↗
• InjuryMar 19, 2022Material Separation; Material Deformation; Material Separation; Material Deformation

  THE USER FACILITY REPORTED THAT THE TIP OF THE GLIDECATH INVOLVED BROKE OFF DURING A CASE. THE BROKEN PIECE WAS ABLE TO BE RETRIEVED AND REMOVED. THE PATIENT WAS UNHARMED AND WAS IN STABLE CONDITION. THE OUTCOME OF THE PROCEDURE WAS POSITIVE. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 01 MAR 2022: THE PROCEDURE PERFORMED WAS A COMMON ILIAC ANGIOPLASTY. THE EVENT OCCURRED AFTER A VERY CHALLENGING CROSSING OF BULKY PLAQUE. THERE WAS AN ABUNDANCE OF FORCE AND FRICTION INVOLVED, AND THE CATHETER WAS IN A WALTMAN LOOP (BENT BACK ON ITSELF). THE DEVICE BROKE ABOUT TEN CENTIMETERS BACK FROM THE TIP. WHEN THE CATHETER WAS REMOVED, THE TIP STAYED IN THE AORTA. A SNARE WAS USED TO REMOVE THE BROKEN PIECE WITHIN ONE MINUTE, AND THERE WAS ZERO HARM DONE. THERE WAS NO BLOOD LOSS. THE BROKEN TIP WAS REMOVED IN ITS ENTIRETY AS A SINGLE PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13825359 ↗
• InjuryMar 19, 2022Material Separation; Material Deformation; Material Separation; Material Deformation

  THE USER FACILITY REPORTED THAT THE TIP OF THE GLIDECATH INVOLVED BROKE OFF DURING A CASE. THE BROKEN PIECE WAS ABLE TO BE RETRIEVED AND REMOVED. THE PATIENT WAS UNHARMED AND WAS IN STABLE CONDITION. THE OUTCOME OF THE PROCEDURE WAS POSITIVE. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 01 MAR 2022: THE PROCEDURE PERFORMED WAS A COMMON ILIAC ANGIOPLASTY. THE EVENT OCCURRED AFTER A VERY CHALLENGING CROSSING OF BULKY PLAQUE. THERE WAS AN ABUNDANCE OF FORCE AND FRICTION INVOLVED, AND THE CATHETER WAS IN A WALTMAN LOOP (BENT BACK ON ITSELF). THE CATHETER BROKE ABOUT TEN CENTIMETERS BACK FROM THE TIP. WHEN THE CATHETER WAS REMOVED, THE TIP STAYED IN THE AORTA. A SNARE WAS USED TO REMOVE THE BROKEN PIECE WITHIN ONE MINUTE, AND THERE WAS ZERO HARM DONE. THERE WAS NO BLOOD LOSS. THE BROKEN TIP WAS REMOVED IN ITS ENTIRETY AS A SINGLE PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13825354 ↗
• MalfunctionNov 22, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDECATH DEVICE WAS USED DURING THE PROCEDURE. THERE WAS AN ISSUE WITH THE ILIAC BIFURCATION AND GETTING UP AND OVER. THE CATHETER BROKE APART; HOWEVER, WAS PULLED OUT OF THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 12NOV2019. THE PATIENT WAS A AAA CANDIDATE AND FEMORAL ACCESS WAS USED. ALTHOUGH THE CATHETER WAS BROKEN, IT WAS CONNECTED BY THE BRAID. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 9362120 ↗
• InjuryOct 28, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDECATH BROKE OFF IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019. WHILE PERFORMING A PERIPHERAL ANGIO OF THE RIGHT GROIN, GOING UP AND OVER IN THE LEFT LEG THE GLIDECATH BROKE OFF. THE CATHETER WAS REMOVED FROM THE PATIENT USING A SNARE. THE PATIENT WAS REPORTED TO BE STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY ONCE REMOVING THE CATHETER. THE BLOOD LOSS WAS LESS THAN 250CC'S.

  Patient problems: Blood Loss

  MAUDE report 9245242 ↗
• InjuryOct 28, 2019Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDECATH BROKE OFF IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 16OCT2019. WHILE PERFORMING A PERIPHERAL ANGIO OF THE RIGHT GROIN, GOING UP AND OVER IN THE LEFT LEG THE GLIDECATH BROKE OFF. THE CATHETER WAS REMOVED FROM THE PATIENT USING A SNARE. THE PATIENT WAS REPORTED TO BE STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY ONCE REMOVING THE CATHETER. THE BLOOD LOSS WAS LESS THAN 250 CC'S.

  Patient problems: Blood Loss

  MAUDE report 9245238 ↗
• InjuryAug 14, 2017Break; Break

  THE USER FACILITY REPORTED THE FOLLOWING THAT WAS RECEIVED THROUGH A USER FACILITY MEDWATCH (B)(4). "DIFFICULT REMOVAL OF IVC FILTER IN OPERATIN ROOM (OR). IVD FILTER HAD BEEN PLACED MONTHS EARLIER PRIOR TO A GASTRIC BYPASS. THE REMOVAL PROCEDURE WAS PROLONGED (TWO HOURS) AS OPPOSED TO A TYPICAL 30 MINUTES. A STANDARD PROTOCOL CHEST X-RAY POST-SURGERY REVEALED THE RETENTION OF A FOREIGN BODY IN PULMONARY ARTERY. SUCCESSFUL RETRIEVAL BY INTERVENTIONAL RADIOLOGIST OF 37 CM FOREIGN BODY WHICH APPEARS TO REPRESENT A "STRETCHED, FRACTURED SECTION" OF A GLIDECATH (ANGIOGRAPHIC CATHETER). WHAT WAS THE ORIGINAL INTENDED PROCEDURE? REMOVAL OF IVC FILTER." "IT WAS A DIFFICULT IVC FILTER REMOVAL REQUIRING SEVERAL ATTEMPTS BY INITIAL SURGEON AND THEN SUBSEQUENTLY, THE INTERVENTIONAL SURGEON.: IT WAS REPORTED THAT "YES, THERE IS A POSSIBILITY THAT THE IVC FILTER REMOVAL MAY HAVE SHEARED THE CATH." ADDITIONAL INFORMATION WAS RECEIVED ON JULY 28, 2017. THE PATIENT WAS REPORTED TO BE STABLE AND DOING WELL. THEY SUCCESSFULLY REMOVED THE IVC FILTER AND HAD A SUCCESSFUL REMOVAL OF THE RETAINED PRODUCT.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6792347 ↗