GLIDESHEATH SLENDER TIBIAL PEDAL KIT 52-1050Recalls & reported problems
Terumo Medical Corporation · GLIDESHEATH SLENDER Tibial Pedal Kit, 40mm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00389701012346), received between Jun 22, 2020 and Aug 19, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unraveled Material2
- Material Deformation1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50324724 ↗MalfunctionAug 19, 2026Unraveled Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50324422 ↗InjuryJun 22, 2020Unraveled Material; Material Deformation; Unraveled Material; Material Deformation
THE USER FACILITY REPORTED THAT THE INVOLVED GLIDESHEATH SLENDER WAS USED DURING THE PROCEDURE. WHILE ATTEMPTING DP ACCESS THE WIRE BUNCHED UP. WHEN RETRACTED, THE WIRE UNRAVELED, AND A PIECE WAS LEFT INSIDE THE PATIENT. THE WIRE PIECE WAS IN THE OCCLUDED SEGMENT AND THEREFORE DID NOT IMPACT THE OUTCOME. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE OUTCOME WAS A FAILURE. THE NEEDLE AND WIRE FROM THE SAME KIT WAS USED. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 01JUN2020. DP ACCESS MEANS DORSALIS PEDIS - PEDAL ACCESS. THE DOCTOR WAS UNABLE TO REMOVE THE WIRE; THERE WAS NO TESTING PERFORMED REGARDING WIRE MOVEMENT. THE PROCEDURE WAS COMPLETED FROM FEMORAL ACCESS. THE PATIENT DID NOT SUFFER FROM ANY VESSEL/TISSUE TRAUMA, VESSEL OCCLUSION, THROMBOSIS OR BLEEDING.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10178152 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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