Halo One™ Thin-Walled Guiding Sheath HLO42535HRecalls & reported problems
Clearstream Technologies Limited · Halo One 4F guiding sheath diameter,25 cm shaft length, including 035 Dilator with hydrophilic coating · 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741184826), received between Dec 17, 2021 and Dec 24, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation2
- Device Contamination with Chemical or Other Material1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 24, 2025Material Deformation; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT RECANALIZATION PROCEDURE USING HALO ONE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE SHEATH HAD A MISSING CORNER AT THE FRONT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23887576 ↗MalfunctionDec 24, 2025Material Deformation; Material Deformation
ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE HALO ONE DEVICE. IT WAS REPORTED THAT THE SCREW THREAD WAS DAMAGED AND COULD NOT BE TIGHTENED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE, AND THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23887194 ↗MalfunctionOct 15, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY VIA A RETROGRADE APPROACH, THE TIP OF THE SHEATH ALLEGEDLY SPLIT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15612506 ↗MalfunctionDec 17, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THERE WAS FOREIGN SUBSTANCE LIKE WHITE POWER WAS OBSERVED ON THE TIP OF THE SHEATH. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13023671 ↗
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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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