Halo One™ Thin-Walled Guiding Sheath HLO44535Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741161841), received between Apr 26, 2021 and Mar 18, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Difficult to Insert; Material Deformation

  ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE BY USING HALO ONE. IT WAS REPORTED THAT DURING PROCEDURE THE TIP ALLEGEDLY CURLED DURING SHEATH INSERTION CAUSES INSERTION DIFFICULTY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625640 ↗
• MalfunctionMay 5, 2025Connection Problem; Connection Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE LIFESTREAM. PRIOR TO THE PROCEDURE, THE CATHETER WAS OPENED FROM THE BOX AND FLUSHED WITH SALINE. UPON CHECKING TO SEE IF THE HEMOSTASIS VALVE WAS CLOSED, IT ROTATED AND COULD NOT BE LOCKED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21958405 ↗
• MalfunctionMay 23, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE INTRODUCER SHEATH TIP ALLEGEDLY FLIPPED DURING INSERTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378917 ↗
• MalfunctionApr 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, BLOOD ALLEGEDLY LEAKED FROM BETWEEN THE CONNECTION PART OF THE HUB AND THE CATHETER SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16789855 ↗
• MalfunctionApr 18, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A TARGET LESION BELOW THE KNEE, THE DEVICE ALLEGEDLY UNABLE TO ASPIRATE BLOOD UPON A CONTRAST EXAMINATION AND THE HEMOSTATIC VALVE WAS FOUND DEFECTIVE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED BY DETACHING THE HEMOSTATIC VALVE AND ATTACHING THE 3-WAY STOPCOCK. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761201 ↗
• MalfunctionMar 4, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE LUER LOCK OF THE DEVICE ALLEGEDLY COULD NOT BE SCREWED TIGHT TO THE SHEATH AND THE SHEATH OPENED BY IT SELF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13665343 ↗
• InjuryNov 3, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED CATHETER PLACEMENT PROCEDURE IN THE COMMON FEMORAL ARTERY, THE DILATOR WAS ALLEGEDLY UNABLE TO BE TRACKED SMOOTHLY INTO THE ARTERY. THE ANGLE HAD TO BE ALTERED TO GAIN ACCESS. IT WAS FURTHER REPORTED THAT THE ARTERY HAD TO BE COMPRESSED FOR FORTY MINUTES TO STOP THE BLEEDING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12745060 ↗
• MalfunctionApr 26, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA IPSILATERAL ANTEGRADE APPROACH, A VISCOUS SUBSTANCE WAS ALLEGEDLY FOUND ON COATING PART OF SHEATH, WHEN THE SHEATH WAS WETTED WITH SALINE. IT WAS FURTHER REPORTED THAT THE SUBSTANCE WAS WIPED CLEAN AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722842 ↗