Halo One Thin-Walled Guiding Sheath HLO67035Recalls & reported problems
Clearstream Technologies Limited · Halo One 6F guiding sheath diameter, 70cm shaft length, 0.035 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741223884), received between Nov 7, 2024 and May 2, 2025 — classified as 3 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
- Failure to Advance1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 2, 2025Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn
ON (B)(6) 2025 A PATIENT UNDERWENT A PROCEDURE USING A HALO ONE DEVICE. DURING THE PROCEDURE, THE SHEATH WAS FAILED TO ADVANCE THROUGH THE COMMON ILIAC ARTERY. IT WAS FURTHER REPORTED THAT THERE WAS NO STENOSIS OR DISEASE IN THE ARTERY. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. UPON REMOVAL, THE END OF THE DILATOR WAS CRACKED UP THE SIDE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21947761 ↗MalfunctionNov 15, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE INTRODUCER SHEATH ALLEGEDLY FLATTENED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20693183 ↗MalfunctionNov 7, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE SHEATH WAS ALLEGEDLY CRUSHED AND FLATTENED AT THE BOTTOM. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20628107 ↗
Other INTRODUCER, CATHETER devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page