Halo One™ Thin-Walled Guiding Sheath HLO41035FRecalls & reported problems
Clearstream Technologies Limited · 4F guiding sheath diameter, 10 cm shaft length, including 035 Dilator, Multipack of five · 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 00801741161827), received between Nov 9, 2020 and May 31, 2022 — 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.
Most reported problems
Device problems
- Material Deformation2
- Break1
- Connection Problem1
- Device Damaged Prior to Use1
- Material Separation1
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.
MalfunctionMay 31, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DILATOR ALLEGEDLY GOT SPLIT WHILE INSERTING INTO THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14545690 ↗MalfunctionMay 31, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DILATOR ALLEGEDLY GOT SPLIT WHILE INSERTING INTO THE VESSEL. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14545689 ↗MalfunctionMar 11, 2021Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT DURING THE REMOVAL PROCEDURE THROUGH FEMORAL REGION, THE TIP OF THE CATHETER WAS ALLEGEDLY BROKEN AND SEPARATED FROM THE OPAQUE MARK. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11460120 ↗MalfunctionNov 9, 2020Device Damaged Prior to Use; Connection Problem; Device Damaged Prior to Use; Connection Problem
IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE CONNECTION BETWEEN LUERLOCK AND SHEATH ARE ALLEGEDLY LOOSEN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10807277 ↗
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
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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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