GLIDECATHRecalls & reported problems across all models
Terumo Corporation · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls
- 0
We found 9 models of GLIDECATH by Terumo Corporation in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2017 and Nov 5, 2025 — classified as 50 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Break” (20 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported GLIDECATH problems
Device problems
- Break20
- Material Separation18
- Fracture12
- Material Deformation3
- Detachment Of Device Component2
- Physical Resistance/Sticking2
- Material Rupture1
- Mechanical Jam1
Patient problems
- Foreign Body In Patient26
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient6
- No Code Available4
- Blood Loss3
- Calcium Deposits/Calcification2
- Device Embedded In Tissue or Plaque2
- No Information2
GLIDECATH models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GLIDECATH CG415CATHETER, INTRAVASCULAR, DIAGNOSTIC28 reports
- GLIDECATH CG416CATHETER, INTRAVASCULAR, DIAGNOSTIC12 reports
- GLIDECATH CG412CATHETER, INTRAVASCULAR, DIAGNOSTIC7 reports
- GLIDECATH CG417CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- GLIDECATH CG409CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- GLIDECATH RF*WA25110MCATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- GLIDECATH CG507CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- GLIDECATH CG508CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- GLIDECATH CG511CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
Recent GLIDECATH adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryOct 31, 2025Fracture; Fracture
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE GLIDECATH BROKE IN HALF IN THE BODY. IT WAS STILL ATTACHED TO THE WIRE, AND THEY SNARED IT OUT. ADDITIONAL INFORMATION WAS RECEIVED ON 08OCT2025: THERE WAS NO PATIENT INJURY AND THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 09OCT2025: THERE WERE NO FRAGMENTS LEFT IN THE BODY; IT WAS SNARED OUT.
Patient problems: Foreign Body In Patient
MAUDE report 23442330 ↗InjuryOct 31, 2025Fracture; Fracture
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE GLIDECATH BROKE IN HALF IN THE BODY. IT WAS STILL ATTACHED TO THE WIRE, AND THEY SNARED IT OUT. ADDITIONAL INFORMATION WAS RECEIVED ON 08OCT2025: THERE WAS NO PATIENT INJURY AND THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 09OCT2025: THERE WERE NO FRAGMENTS LEFT IN THE BODY; IT WAS SNARED OUT.
Patient problems: Foreign Body In Patient
MAUDE report 23442328 ↗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 ↗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 ↗InjuryMar 4, 2025Fracture; Fracture
THE USER FACILITY REPORTED THAT WHILE INSERTED IN THE AORTA, 15CM'S OF THE TIP BROKE OFF IN THE PATIENT AND IT TOOK AN HOUR FOR IT TO BE RETRIEVED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: THE PROCEDURE PERFORMED WAS AN AORTOGRAM, RIGHT LEG ANGIOGRAM, LEFT ILIAC ANGIOPLASTY, AND RETRIEVAL INTRAVASCULAR DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: THE PATIENT WAS STABLE AND WENT HOME THE SAME DAY. CATHETER BROKE OFF WHILE CROSSING AN ILIAC STENOSIS GETTING INTO THE ABDOMINAL AORTA FOR AN ANGIOGRAM. BLOOD LOSS WAS MINIMAL. A STIFF AMPLATZ WIRE WAS THROUGH THE CATHETER AT THE TIME IT SNAPPED OFF. IT WAS RETRIEVED WITH A SNARE CATHETER.
Patient problems: Foreign Body In Patient
MAUDE report 21521098 ↗InjuryMar 4, 2025Fracture; Fracture
THE USER FACILITY REPORTED THAT WHILE INSERTED IN THE AORTA, 15CM'S OF THE TIP BROKE OFF IN THE PATIENT AND IT TOOK AN HOUR FOR IT TO BE RETRIEVED. ADDITIONAL INFORMATION WAS RECEIVED ON 06FEB2025: THE PROCEDURE PERFORMED WAS AN AORTOGRAM, RIGHT LEG ANGIOGRAM, LEFT ILIAC ANGIOPLASTY, AND RETRIEVAL INTRAVASCULAR DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON 11FEB2025: THE PATIENT WAS STABLE AND WENT HOME THE SAME DAY. CATHETER BROKE OFF WHILE CROSSING AN ILIAC STENOSIS GETTING INTO THE ABDOMINAL AORTA FOR AN ANGIOGRAM. BLOOD LOSS WAS MINIMAL. A STIFF AMPLATZ WIRE WAS THROUGH THE CATHETER AT THE TIME IT SNAPPED OFF. IT WAS RETRIEVED WITH A SNARE CATHETER.
Patient problems: Foreign Body In Patient
MAUDE report 21521095 ↗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 ↗InjuryJul 16, 2024Material Deformation; Material Deformation
THE USER FACILITY REPORTED DURING A DIAGNOSTIC PANANGIOGRAPHY, THE GLIDE CATH XP CATHETER DEVICE WAS USED, THROUGH RADIAL ACCESS. DURING THE PROCEDURE, AFTER OBTAINING IMAGES THE CATHETER DOES NOT RESPOND TO TORQUE WHEN MANIPULATING. TWO KINKS WERE OBSERVED (DISTAL AND PROXIMAL IN THE CATHETER). HYDROPHILIC GUIDE WAS ADVANCED TO BE ABLE TO REMOVE THE CATHETER, WHICH DEFORMED. THE PAIN DURING CATHETER REMOVAL IN THE RIGHT ARM REQUIRES ANESTHESIA ASSISTANCE FOR SEDATION. THERE WERE NO ADDITIONAL COMPLICATIONS. THE PATIENT EXPERIENCED PAIN DURING REMOVAL OF THE PRODUCT AND WAS TREATED WITH ANESTHESIA. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS HARMED; HOWEVER, NOT SERIOUSLY.
Patient problems: Pain
MAUDE report 19749537 ↗InjuryMay 9, 2024Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE TIP OF AN ENDOVASCULAR "GLIDECATH" WAS NOTED TO BE MISSING AFTER IT WAS REMOVED FROM THE PATIENT. THE SURGEON DID NOT BELIEVE THERE WAS ANY PATIENT HARM, THE PATIENT WAS FINE. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 06MAY2024: NO REPORTED ADVERSE PATIENT EFFECT DUE TO THE INCIDENT. THE PROCEDURE WAS SUCCESSFUL.
Patient problems: Foreign Body In Patient
MAUDE report 19277736 ↗InjuryMay 9, 2024Material Separation; Material Separation
THE USER FACILITY REPORTED THAT THE TIP OF AN ENDOVASCULAR "GLIDECATH" WAS NOTED TO BE MISSING AFTER IT WAS REMOVED FROM THE PATIENT. THE SURGEON DID NOT BELIEVE THERE WAS ANY PATIENT HARM, THE PATIENT WAS FINE. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 06MAY2024: NO REPORTED ADVERSE PATIENT EFFECT DUE TO THE INCIDENT. THE PROCEDURE WAS SUCCESSFUL.
Patient problems: Foreign Body In Patient
MAUDE report 19277666 ↗
Other Terumo Corporation products
All Terumo Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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