Halo One™ Thin-Walled Guiding Sheath HLO57035Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741161933), received between Oct 8, 2020 and Sep 2, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE OF A 5CM CHRONIC TOTAL OCCLUSION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA TAI APPROACH, I WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE DEVICE WAS ALLEGEDLY WETTED WITH SALINE AND WIPED WITH WET GAUZE, SMALL WHITE LUMPS WERE FOUND ADHERING TO THE SHEATH SURFACE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932079 ↗
• MalfunctionSep 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE OF A 5CM CHRONIC TOTAL OCCLUSION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA TAI APPROACH. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE SURFACE OF THE SHEATH FELT ROUGH WHEN THE DEVICE WAS OPENED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY WETTED WITH SALINE AND LIGHTLY WIPED WITH WET GAUZE, REVEALING SMALL WHITE LUMPS ADHERING TO THE SHEATH SURFACE IN SEVERAL PLACES. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931715 ↗
• MalfunctionMar 4, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE OF THE COMMON FEMORAL ARTERY TO ACCESS THE SPLENIC ARTERY ANEURYSM, RESISTANCE WAS ALLEGEDLY FELT WHEN ADVANCING THE DEVICE. THE DEVICE WAS REMOVED OFF THE PATIENT AND UPON EXAMINATION, THE DILATOR TIP OF THE DEVICE WAS ALLEGEDLY NOTED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13665342 ↗
• MalfunctionNov 7, 2021Retraction Problem; Device-Device Incompatibility; Retraction Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT POST AN ANGIOPLASTY PROCEDURE THROUGH PUNCTURE IN THE ARTERIAL BRACHIALIS, THE CATHETER SHAFT WAS ALLEGEDLY UNABLE TO BE REMOVED THROUGH THE DEVICE. THE HEALTH CARE PROFESSIONAL HAD TO REMOVE EVERYTHING TOGETHER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12757272 ↗
• MalfunctionOct 8, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE THE GUIDEWIRE WAS BEING LOADED ON TO THE GUIDING SHEATH, THE GUIDING SHEATH WAS FOUND ALLEGEDLY CONTAMINATED WITH A MILKY SUBSTANCE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10653385 ↗