Halo One™ Thin-Walled Guiding Sheath HLO52535HRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741184857), received between Apr 15, 2021 and Jun 5, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Difficult to Insert; Unraveled Material; Difficult to Insert; Unraveled Material

  A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE HALO ONE SHEATH, THE SHEATH ALLEGEDLY PEELED OFF DURING USE. IT WAS FURTHER REPORTED THAT THE RESISTANCE WAS ALLEGEDLY FELT WHILE INSERTING THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22147495 ↗
• MalfunctionMay 12, 2025Difficult to Insert; Failure to Advance; Material Deformation; Difficult to Insert; Failure to Advance; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE HALO DEVICE VIA IPSILATERAL TO THE SUPERFICIAL FEMORAL ARTERY LESION, THE SHEATH WAS ALLEGEDLY COULD NOT BE INSERTED. IT WAS FURTHER REPORTED THAT THE TIP WAS ALLEGEDLY FOUND TO BE DAMAGED UPON REMOVING FROM THE BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000305 ↗
• MalfunctionFeb 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE SHEATH WAS ALLEGEDLY DEFORMED WHEN INSERTED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353123 ↗
• MalfunctionSep 16, 2024Failure to Advance; Detachment of Device or Device Component; Material Deformation; Failure to Advance; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE MILDLY CALCIFIED BELOW KNEE LESION VIA AN IPSILATERAL APPROACH, THE INTRODUCER SHEATH ALLEGEDLY KINKED AND COULD NOT BE INSERTED. IT WAS FURTHER REPORTED THAT THE SHEATH ALLEGEDLY DETACHED ABOUT FIVE CENTIMETERS FROM THE TIP, END POINT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20233807 ↗
• MalfunctionJul 2, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN SUPERIOR FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE INTRODUCER SHEATH ALLEGEDLY COULD NOT BE INSERTED. IT WAS FURTHER REPORTER THAT THE TIP OF THE INTRODUCER SHEATH WAS ALLEGEDLY TURNED UP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653290 ↗
• MalfunctionDec 29, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA THE IPSILATERAL ANTEGRADE APPROACH, A FEW CENTIMETERS FROM THE TIP OF THE DEVICE WAS ALLEGEDLY CRACKED VERTICALLY. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE ALLEGEDLY CAME OUT FROM THE CRACKED PART. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18417426 ↗
• MalfunctionOct 31, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE TIP OF THE SHEATH ALLEGEDLY GOT SUCK AT THE HARD LESION AND FAILED TO ADVANCE AFTER A FEW INSERTION ATTEMPTS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039406 ↗
• MalfunctionOct 10, 2023Peeled/Delaminated; Failure to Advance; Peeled/Delaminated; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE TIP OF THE SHEATH ALLEGEDLY PEELED AND FAILED TO INSERT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903563 ↗
• MalfunctionJun 2, 2023Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE TIP OF THE SHEATH ALLEGEDLY SPLIT UPON INSERTION. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048672 ↗
• MalfunctionSep 28, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA AN IPSILATERAL ANTEGRADE APPROACH, THE TIP OF THE SHEATH WAS ALLEGEDLY PEELED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS UNABLE TO BE INSERTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499786 ↗
• MalfunctionJun 15, 2022Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA AN ANTEGRADE APPROACH, THE SHEATH WAS ALLEGEDLY DIFFICULT TO INSERT AND FOUND THE TIP OF THE SHEATH DAMAGE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14694472 ↗
• MalfunctionApr 29, 2022Contamination; Contamination

  IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THE PHYSICIAN ALLEGEDLY MADE THE DEVICE LOSS OF STERILITY UPON OPENING PACKAGING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14249260 ↗
• MalfunctionJan 11, 2022Unraveled Material; Device Contamination with Chemical or Other Material; Unraveled Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A GEL LIKE SUBSTANCE WAS ALLEGEDLY IDENTIFIED AT THE TIP OF THE DEVICE UPON INSERTION AFTER BEING WETTED WITH SALINE. THE SUBSTANCE WAS REPORTED TO SEEM LIKE A LUMP OF THE PEELED COATING FROM THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13219308 ↗
• InjuryDec 1, 2021Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE SHEATH WAS ALLEGEDLY UNABLE TO BE INSERTED. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED PAIN. THE PATIENT CURRENT STATUS WAS UNKNOWN.

  Patient problems: Pain

  MAUDE report 12906272 ↗
• MalfunctionMay 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE END OF AN ANGIOPLASTY PROCEDURE, HEMOSTASIS VALVE OF THE DEVICE ALLEGEDLY KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831022 ↗
• MalfunctionApr 15, 2021Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR PROCEDURE, THE DEVICE ALLEGEDLY FELL ON THE FLOOR. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670363 ↗