Super SheathRecalls & reported problems across all models
Togo Medikit CO.,Ltd. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 14 models of Super Sheath by Togo Medikit CO.,Ltd. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Oct 26, 2018 and Dec 17, 2025 — classified as 4 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (12 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 Super Sheath problems
Device problems
- Device Contamination with Chemical or Other Material12
- Device Contaminated During Manufacture or Shipping7
- Break4
- Detachment of Device or Device Component3
- Difficult to Remove2
- Entrapment of Device1
- Fracture1
- Unsealed Device Packaging1
Patient problems
- No Consequences Or Impact To Patient15
- No Patient Involvement6
- No Clinical Signs, Symptoms or Conditions5
- Hemorrhage/Blood Loss/Bleeding2
- Hematoma1
- Vascular Dissection1
Super Sheath models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Super Sheath (15-721B) BT50Z11PPW038INTRODUCER, CATHETER6 reports
- Super Sheath (16035-06B) BT60Z11PGW038INTRODUCER, CATHETER3 reports
- Super Sheath (16037-06B) BT60Z25PPW038INTRODUCER, CATHETER3 reports
- Super Sheath (15-714B) BT80Z11PGW035INTRODUCER, CATHETER3 reports
- Super Sheath (15-712B) BT60Z11PGW035INTRODUCER, CATHETER2 reports
- Super Sheath (15-720B) BT40Z11PPW035INTRODUCER, CATHETER2 reports
- Super Sheath (15-711B) BT50Z11PGW035INTRODUCER, CATHETER2 reports
- Super Sheath (15-712B) BT60Z11PGW035INTRODUCER, CATHETER2 reports
- Super Sheath (16034-04B) BT40Z11PGW035INTRODUCER, CATHETER1 report
- Super Sheath (16035-05B) BT50Z11PGW038INTRODUCER, CATHETER1 report
- Super Sheath (16035-07B) BT70Z11PGW038INTRODUCER, CATHETER1 report
- Super Sheath (15-732B) BT70Z25PPW038INTRODUCER, CATHETER1 report
- Super Sheath (15-707B) BT70Z07PGW035INTRODUCER, CATHETER1 report
- Super Sheath (15-713B) BT70Z11PGW035INTRODUCER, CATHETER1 report
Recent Super Sheath adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DEVICE BROKE OFF, REQUIRING ADDITIONAL INTERVENTION FOR REMOVAL. A 6 FR X 11 CM .035 SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR PLACEMENT. DURING THE PROCEDURE, THERE WAS NO RESISTANCE NOTED WHEN THE SUPER SHEATH DEVICE WAS ADVANCED IN THE VESSEL. HOWEVER, UPON COMPLETION OF THE PROCEDURE, IT WAS NOTED THAT THE DEVICE BROKE UNDER FLUOROSCOPIC VISUALIZATION. AN ATTEMPT WAS MADE TO EXTRACT THE FOREIGN BODY USING A NON-BOSTON SCIENTIFIC (NON-BSC) SNARE, WITHOUT SUCCESS. THE DETACHED PORTION OF THE DEVICE REMAINED IN THE COMMON FEMORAL ARTERY. A NON-BSC 7 FR FEMORAL INTRODUCER WAS THEN REPLACED, FOLLOWED BY AN 8 FR FEMORAL INTRODUCER. THE SYSTEM WAS MOUNTED ON A 7 FR JR 3.5 GUIDE CATHETER, ALSO WITHOUT SUCCESS. ADDITIONALLY, A NON-BSC LOOP-SHAPED ANGIOPLASTY GUIDE WAS USED, BUT AFTER MULTIPLE FAILED ATTEMPTS TO RETRIEVE THE DEVICE, THE PROCEDURE WAS TERMINATED DUE TO THE HIGH RISK OF ASSOCIATED VASCULAR COMPLICATIONS. THE PATIENT UNDERWENT OPEN SURGERY TO EXPLORE AND RETRIEVED THE INTRODUCER SHEATH. THE CARDIAC CATHETERIZATION PROCEDURE WAS COMPLETED. THE PATIENT FULLY RECOVERED POST-PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829396 ↗MalfunctionApr 29, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT SHEATH WAS TORN CAUSING HEMATOMA. A 5 FR X 11 CM .035 INTRODUCER SHEATH WAS SELECTED FOR USE IN A RENAL EMBOLIZATION. DURING THE CLOSURE PROCESS OF THE PROCEDURE, A NON-BOSTON SCIENTIFIC VASCULAR CLOSURE WAS PLACED. UPON RETRACTING THE SHEATH, IT WAS NOTED THAT THE SHEATH TORE IN HALF CAUSING A HEMATOMA. MANUAL PRESSURE WAS APPLIED TO THE INCISION SITE. BOTH PARTS OF THE SHEATH WERE RECOVERED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.
Patient problems: Hematoma
MAUDE report 21927941 ↗MalfunctionApr 17, 2025Break; Break
IT WAS REPORTED THAT A HOLE IN THE SHEATH OCCURRED. A 7 FR X 25 CM SUPER SHEATH INTRODUCER SHEATH WAS PLACED INTO THE ARM OVER THE WIRE FOR TREATING SLOW FLOW FISTULA PROCEDURE. THE WIRE WAS REMOVED AND TOOK AN ANGIOGRAPHY OF THE ARM BY INJECTING THE CONTRAST THROUGH THE SHEATH. HOWEVER, THE CONTRAST WAS FOUND COMING OUT OF THE TIP OF THE SHEATH. ANOTHER CONTRAST WAS SHOT, AND IT WAS CONFIRMED THAT THE CONTRAST WAS COMING OUT IN THE MIDDLE PART OF THE SHEATH. THE DEVICE WAS REMOVED AND FOUND A HOLE IN IT. ANOTHER SHEATH OF THE SAME SIZE AND TYPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21854136 ↗InjuryJun 27, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SHEATH SEPARATED INSIDE THE BODY AND ADDITIONAL INTERVENTION WAS NEEDED TO REMOVE THE FRAGMENT. THIS SUPER SHEATH INTRODUCER SHEATH 6 FR X 11 CM .035 WAS SELECTED FOR PATENT FORAMEN OVALE (PFO) PROCEDURE WITH AN EXPERIENCED CARDIOLOGIST. PREPARATION OF THE SHEATH WAS FLUSHED/COMPLETED AND SHOWED NO ABNORMALITY. DURING THE PROCEDURE, UPON THE SECOND USE, THE OPERATOR HAD DIFFICULTY REMOVING THE SHEATH FROM THE VESSEL CAUSING THE SHEATH TO SEPARATE INSIDE THE PATIENT. ADDITIONAL INTERVENTION WAS PERFORMED TO OPEN THE VESSEL AND REMOVE THE BROKEN SHEATH FRAGMENT FROM THE PATIENT. DURING THE INTERVENTION, THE PATIENT LOST A LOT OF BLOOD. THE PATIENT HAD A PROLONGED HOSPITALIZATION; HOWEVER, WAS EXPECTED TO FULLY RECOVER. ANOTHER SUPER SHEATH WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19622758 ↗MalfunctionApr 10, 2024Break; Break
IT WAS REPORTED THAT THE SHEATH WAS BROKEN OR FRACTURED. A 6 FR X 11CM .035 SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SHEATH WAS BROKEN OR FRACTURED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19082996 ↗MalfunctionMay 5, 2023Break; Break
IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. A 7FRX11 CM .035 GW SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE INTRODUCER WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16882244 ↗InjuryMay 23, 2022Break; Break
IT WAS REPORTED THAT THE INTRODUCER WAS FRACTURED AND THE CANNULA HAD TO BE REMOVED THROUGH AN INTRAVASCULAR RETRIEVER. THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON FEMORAL ARTERY. A 6FR X 11CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING REMOVAL, IT WAS NOTED THAT THE INTRODUCER GOT FRACTURED AND THE CANNULA WAS LEFT INSIDE THE PATIENT. CONSEQUENTLY, AN INTRAVASCULAR RETRIEVER HAD TO BE USED FOR ITS EXTRACTION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14469050 ↗InjuryNov 24, 2020Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT THE DEVICE LOCKED ON THE WIRE AND A DISSECTION OCCURRED. A 5F X 11CM SUPER SHEATH INTRODUCER SHEATH WITH 0.038IN MINI GUIDEWIRE WAS SELECTED FOR USE IN A PROCEDURE WITHIN THE FEMORAL ARTERY. THE POST-DILATED TARGET LESION WAS 300MM LONG WITH NO CALCIFICATION. DURING THE PROCEDURE, THE MINI GUIDEWIRE LOCKED ON TO THE NON-BOSTON SCIENTIFIC INTRODUCER NEEDLE. THE SUPER SHEATH INTRODUCER SHEATH WAS NEVER ADVANCED INSIDE THE BODY; ONLY THE MINI GUIDEWIRE THAT WAS PROVIDED WITH THE DEVICE WAS INSIDE THE BODY. THERE WAS BLEEDING FROM A SMALL RIFT IN THE VESSEL THAT REQUIRED EXTRA HAND COMPRESSION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection
MAUDE report 10897154 ↗MalfunctionJul 23, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A WET FILM INSIDE THE STERILE PACKAGE WAS FOUND. A WET FILM WAS NOTED INSIDE THE STERILE PACKAGING OF A 6FX11CM SUPER SHEATH INTRODUCER SHEATH. THE OILY RESIDUE WAS SEEN INSIDE THE PACKAGE NEAR THE DEVICE HUB. WHEN THE PACKAGE WAS OPENED, IT WAS ALMOST OILY WHEN FELT. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10314250 ↗MalfunctionJul 23, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A WET FILM INSIDE THE STERILE PACKAGE WAS FOUND. A WET FILM WAS NOTED INSIDE THE STERILE PACKAGING OF A 6FX25CM SUPER SHEATH INTRODUCER SHEATH. THE OILY RESIDUE WAS SEEN INSIDE THE PACKAGE NEAR THE DEVICE HUB. WHEN THE PACKAGE WAS OPENED, IT WAS ALMOST OILY WHEN FELT. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10314223 ↗MalfunctionJul 23, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A WET FILM INSIDE THE STERILE PACKAGE WAS FOUND. A WET FILM WAS NOTED INSIDE THE STERILE PACKAGING OF A 6FX25CM SUPER SHEATH INTRODUCER SHEATH. THE OILY RESIDUE WAS SEEN INSIDE THE PACKAGE NEAR THE DEVICE HUB. WHEN THE PACKAGE WAS OPENED, IT WAS ALMOST OILY WHEN FELT. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10314214 ↗MalfunctionJul 23, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A WET FILM INSIDE THE STERILE PACKAGE WAS FOUND. A WET FILM WAS NOTED INSIDE THE STERILE PACKAGING OF A 7FX11CM SUPER SHEATH INTRODUCER SHEATH. THE OILY RESIDUE WAS SEEN INSIDE THE PACKAGE NEAR THE DEVICE HUB. WHEN THE PACKAGE WAS OPENED, IT WAS ALMOST OILY WHEN FELT. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10314183 ↗MalfunctionJul 21, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A WET FILM INSIDE THE STERILE PACKAGE WAS FOUND. A WET FILM WAS NOTED INSIDE THE STERILE PACKAGING OF A 6FX25CM SUPER SHEATH INTRODUCER SHEATH. THE OILY RESIDUE WAS SEEN INSIDE THE PACKAGE NEAR THE DEVICE HUB. WHEN THE PACKAGE WAS OPENED, IT WAS ALMOST OILY WHEN FELT. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10304655 ↗MalfunctionJul 21, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A WET FILM INSIDE THE STERILE PACKAGE WAS FOUND. A WET FILM WAS NOTED INSIDE THE STERILE PACKAGING OF A 4FX11CM SUPER SHEATH INTRODUCER SHEATH. THE OILY RESIDUE WAS SEEN INSIDE THE PACKAGE NEAR THE DEVICE HUB. WHEN THE PACKAGE WAS OPENED, IT WAS ALMOST OILY WHEN FELT. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10304627 ↗MalfunctionApr 8, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A FOREIGN MATERIAL WAS PRESENT INSIDE THE DEVICE PACKAGING. A 5FRX11CM .035 SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING UNPACKING, WHEN THE DEVICE WAS OPENED, IT WAS NOTICED THAT A HAIR WAS INSIDE THE PACKAGING. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9937997 ↗
Other Togo Medikit CO.,Ltd. products
All Togo Medikit CO.,Ltd. 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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