Halo One™ Thin-Walled Guiding Sheath HLO51035FRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741161902), received between Jul 16, 2020 and Jun 18, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE HALO DEVICE. DURING THE PROCEDURE, WHEN INSERTING THE SHEATH, THE OBTURATOR SPLIT. IT WAS FURTHER REPORTED THAT THIS HAPPENED EVEN ON ONE INSERTION AND EVEN TWICE ON A NEW 5FR. SHEATH, MEANING TWO PIECES WERE UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22268580 ↗
• MalfunctionJun 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE HALO DEVICE. DURING THE PROCEDURE, WHEN INSERTING THE SHEATH, THE OBTURATOR SPLIT. IT WAS FURTHER REPORTED THAT THIS HAPPENED EVEN ON ONE INSERTION AND EVEN TWICE ON A NEW 5FR. SHEATH, MEANING TWO PIECES WERE UNUSABLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22268530 ↗
• MalfunctionJun 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE HALO ONE THIN-WALLED GUIDING SHEATH AND IT CAME TO THE NOTICE THAT THE DILATATOR WAS ALLEGEDLY SPLIT ON VESSEL WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122229 ↗
• MalfunctionMay 29, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE STENOTIC LESION VIA AN IPSILATERAL APPROACH, THE HEMOSTASIS VALVE WAS ALLEGEDLY NOT LEAK TIGHT AND THE BLOOD CAME OUT. IT WAS FURTHER REPORTED THAT DURING FLUSHING, THE SODIUM CHLORIDE SOLUTION WAS ALLEGEDLY FOUND TO BE SQUIRTED OUT THE BACK OF THE MEMBRANE, THEY USED THE SLUICE ANYWAY, BUT THE MEMBRANE WAS DEFINITELY NOT TIGHT, AND SOME BLOOD ALWAYS CAME OUT. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19414202 ↗
• MalfunctionJul 6, 2021Device Damaged Prior to Use; Failure to Advance; Material Deformation; Device Damaged Prior to Use; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING THE PROCEDURE THROUGH COMMON FEMORAL ANTEGRADE, THE SHEATH ALLEGEDLY HAD A LONGITUDINAL SPLIT AT THE DISTAL PORTION. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO ADVANCE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12121346 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF HEMATOMA, THE DEVICE ALLEGEDLY PERFORATED THE VESSEL. IT WAS FURTHER REPORTED THAT THE VESSEL WAS RESTORED AND HEMATOMA WAS SURGICALLY REMOVED. THE PATIENT STATUS WAS STABLE.

  Patient problems: Perforation

  MAUDE report 11783414 ↗
• InjuryMay 5, 2021Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT HEMATOMA WITH A PUNCTURE IN THE GROIN, THE DEVICE COULD NOT BE INSERTED INTO THE VESSEL. UPON REMOVAL, IT WAS NOTICED THAT THE DILATOR WAS SPLIT. IT WAS FURTHER REPORTED THAT THE VESSEL WAS FOUND TO BE INJURED. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TREATED SURGICALLY. THE PATIENT IS REPORTED TO BE IN A STABLE CONDITION, POST SURGERY.

  Patient problems: Perforation

  MAUDE report 11777652 ↗
• InjuryMay 5, 2021Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT HEMATOMA WITH A PUNCTURE IN THE GROIN, THE DEVICE COULD NOT BE INSERTED INTO THE VESSEL. UPON REMOVAL, IT WAS NOTICED THAT THE DILATOR WAS SPLIT. IT WAS FURTHER REPORTED THAT THE VESSEL WAS FOUND TO BE INJURED. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS TREATED SURGICALLY. THE PATIENT IS REPORTED TO BE IN A STABLE CONDITION, POST SURGERY.

  Patient problems: Perforation

  MAUDE report 11775324 ↗
• InjuryMar 19, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LUER LOCK CANNOT BE PROPERLY CONNECTED. IT WAS REPORTED THAT THE SHEATH OPENED BY ITSELF AND THE PATIENT EXPERIENCE SIGNIFICANT BLOOD LOSS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11525759 ↗
• MalfunctionJul 16, 2020Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL HLO51035F THIN-WALLED GUIDING SHEATH ALLEGEDLY EXPERIENCED SHEATH DILATOR BROKE AND THE DISTAL TIP SPLIT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT'S AGE, SEX AND WEIGHT WERE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10284147 ↗