Halo One Thin-Walled Guiding Sheath HLO52535HKRecalls & reported problems
Clearstream Technologies Limited · 5F guiding sheath diameter, 25cm shaft length, 0.035 dilator, hydrophilic coated, including access kit. · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741223846), received between Jun 22, 2022 and Jun 22, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Body Fluid” (1 report).
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
- Device Contamination with Body Fluid1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2022Device Contamination with Body Fluid; Device Contamination with Chemical or Other Material; Device Contamination with Body Fluid; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE DEVICE ALLEGEDLY HAD PLASTIC PARTICLES ON THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14768666 ↗
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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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