Halo One™ Thin-Walled Guiding Sheath HLO41035Recalls & reported problems
Clearstream Technologies Limited · 4F guiding sheath diameter, 10 cm shaft length, including 035 Dilator · Class 2
All models of Halo One Thin-Walled Guiding Sheath (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741161803), received between Aug 13, 2023 and Nov 26, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance2
- Difficult to Insert1
- Material Deformation1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2024Difficult to Insert; Failure to Advance; Material Deformation; Difficult to Insert; Failure to Advance; Material Deformation
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA AN IPSILATERAL APPROACH, THE SHEATH ALLEGEDLY COULD NOT BE INSERTED. IT WAS FURTHER REPORTED THAT THE TIP HAD ALLEGEDLY CURLED UP. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20786207 ↗MalfunctionAug 13, 2023Unraveled Material; Failure to Advance; Unraveled Material; Failure to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION IN THE RIGHT COMMON FEMORAL ARTERY, THE DEVICE ALLEGEDLY GOT STUCK WITH THE CALCIFY AND FAILED TO INSERT. IT WAS FURTHER REPORTED THAT THE TIP OF THE SHEATH WAS ALLEGEDLY FOUND TO BE PEELED OFF UPON REMOVING OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17538039 ↗
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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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