Halo One™ Thin-Walled Guiding Sheath HLO61035Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00801741161957), received between Aug 2, 2021 and Sep 8, 2026 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (30 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Material Deformation

  On (b)(6) 2026, a patient underwent a recanalization procedure for ipsilateral SFA treatment using a Halo One device. During the procedure, the tip of the sheath curled up, rendering it unusable. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667730 ↗
• MalfunctionApr 13, 2026Material Deformation

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING HALO ONE DEVICE. DURING THE PROCEDURE, THE TIP OF THE SHEATH CURLED UP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24854427 ↗
• MalfunctionDec 30, 2025Material Deformation; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING HALO ONE. IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE DEVICE ALLEGEDLY CANNOT BE USED DUE TO BENT TIP OF HALO ONE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919884 ↗
• MalfunctionNov 19, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE HALO ONE DEVICE. IT WAS REPORTED THAT, DURING INSERTION OF THE GUIDING SHEATH, THE TIP WAS FRAYED AND COULD NOT BE INSERTED PROPERLY. CALCIFICATION WAS ALSO OBSERVED ON THE PRELIMINARY CT SCAN, AND IT WAS THOUGHT THAT THIS AFFECTED THE INSERTION SITE. THE PROCEDURE WAS COMPLETED AFTER SWITCHING TO A THICKER GUIDING SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591261 ↗
• MalfunctionOct 13, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE HALO DEVICE VIA RADIAL ACCESS THE DEVICE HAD A STRONG RESISTANCE AND COULD NOT BE INSERTED. IT WAS FURTHER REPORTED THAT THE DEVICE HAD SLIGHT DEFORMATION AT THE TIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23275935 ↗
• MalfunctionMay 6, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT FOR AN ANGIOPLASTY PROCEDURE IN IPSILATERAL SFA CASE USING HALO ONE. DURING THE PROCEDURE, THE TIP OF THE SHEATH BECAME TURNED UP, MAKING IT IMPOSSIBLE TO INSERT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965941 ↗
• MalfunctionApr 17, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING AN IPSILATERAL PROGRESSIVE APPROACH PROCEDURE USING THE SHEATH, A SLIGHT RESISTANCE WAS FOUND WHILE INSERTION DUE TO CALCIFICATION. ADDITIONALLY, THE SHEATH WAS FOUND TO BE FRAYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859815 ↗
• MalfunctionFeb 27, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE INTRODUCER SHEATH TIP WAS ALLEGEDLY FRAYED. IT WAS FURTHER REPORTED THAT THE INTRODUCER SHEATH COULD NOT BE ALLEGEDLY INSERTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21477076 ↗
• MalfunctionFeb 24, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE INTRODUCER SHEATH WAS ALLEGEDLY DIFFICULT TO BE INSERTED. IT WAS FURTHER REPORTED THAT THE INTRODUCER SHEATH TIP WAS ALLEGEDLY WAS WAVY AFTER REPEATED ATTEMPTS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444940 ↗
• MalfunctionFeb 4, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE TIP OF THE SHEATH BECAME ALLEGEDLY FRAYED DUE TO CALCIFICATION OF THE PUNCTURE SITE AND HAD TO BE REINSERTED MANY TIMES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21302276 ↗
• MalfunctionDec 23, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE AFTER PUNCTURING THE RIGHT COMMON FEMORAL ARTERY IN AN ANTEGRADE MANNER, THE INTRODUCER SHEATH ALLEGEDLY COULD NOT BE INSERTED INTO THE VEIN. IT WAS FURTHER REPORTED THAT, THE TIP OF THE SHEATH ALLEGEDLY CURLED UP DURING REMOVAL OF THE SHEATH FROM THE BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20998834 ↗
• MalfunctionNov 29, 2024Difficult to Insert; Detachment of Device or Device Component; Material Deformation; Difficult to Insert; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE TIP OF THE INTRODUCER SHEATH ALLEGEDLY TURNED UP. IT WAS FURTHER REPORTED THAT ALLEGEDLY THERE WAS SOME DIFFICULTY WHILE INSERTING THE SHEATH. REPORTEDLY, THE SHEATH AND DILATOR ALLEGEDLY DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20810645 ↗
• MalfunctionOct 21, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE INTRODUCER SHEATH ALLEGEDLY HAD RESISTANCE WHILE INSERTING. IT WAS FURTHER REPORTED THAT THE TIP OF THE INTRODUCER SHEATH WAS ALLEGEDLY TURNED OVER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20491021 ↗
• MalfunctionSep 6, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE HEMOSTASIS VALVE WAS DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155952 ↗
• MalfunctionAug 15, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY LESION VIA AN IPSILATERAL APPROACH, THE INTRODUCER SHEATH ALLEGEDLY COULD NOT BE INSERTED. IT WAS FURTHER REPORTED THAT THE TIP OF THE SHEATH OUTER TUBE WAS ALLEGEDLY DEFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19989532 ↗
• MalfunctionJul 18, 2024Difficult to Insert; Detachment of Device or Device Component; Material Deformation; Difficult to Insert; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE INTRODUCER SHEATH ALLEGEDLY KINKED OCCURRED WHILE ATTEMPTING TO INSERT THE SHEATH FROM PUNCTURE SITE. IT WAS FURTHER REPORTED THAT THE SHEATH ALLEGEDLY DETACHED TEN CENTIMETERS FROM DISTAL AND ALSO FELT RESISTANCE DURING SHEATH INSERTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19769242 ↗
• MalfunctionMay 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE HEMOSTATIC VALVE OF THE INTRODUCER SHEATH WAS ALLEGEDLY COULD NOT BE FIXED AND BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398160 ↗
• MalfunctionApr 11, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE HEMOSTASIS VALVE THAT CAME WITH THE SHEATH ALLEGEDLY BECAME LOOSE AND COULD NOT BE ATTACHED FIRMLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086426 ↗
• MalfunctionApr 10, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE TIP OF THE SHEATH ALLEGEDLY FRAYED AND COULD NOT BE INSERTED INTO THE BLOOD VESSEL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077033 ↗
• MalfunctionApr 6, 2024Difficult to Insert; Detachment of Device or Device Component; Material Deformation; Difficult to Insert; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE RIGHT EXTERNAL ILIAC ARTERY VIA THE FEMORAL IPSILATERAL RETROGRADE APPROACH, THE DEVICE WAS ALLEGEDLY DIFFICULT TO INSERT. IT WAS FURTHER REPORTED THAT THE TIP OF THE SHEATH WAS ALLEGEDLY FOUND TO BE MISSING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19056554 ↗
• MalfunctionMar 26, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE COMMON FEMORAL ARTERY VIA AN IPSILATERAL RETROGRADE APPROACH, THE DEVICE ALLEGEDLY DID NOT PROGRESS DUE TO SEVERE CALCIFICATION. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976844 ↗
• MalfunctionJan 24, 2024Difficult to Insert; Material Deformation; Material Split, Cut or Torn; Difficult to Insert; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERIOR FEMORAL ARTERY VIA AN IPSILATERAL APPROACH, A RESISTANCE WAS FELT, AND THE SHEATH WAS ALLEGEDLY UNABLE TO BE INSERTED. IT WAS FURTHER REPORTED THAT THE TIP OF THE DILATOR WAS ALLEGEDLY RIPPED, AND THE GUIDEWIRE WAS HOOKED INTO THE TEAR. REPORTEDLY, WHEN THE GUIDEWIRE WAS REMOVED FROM THE TEAR, THE TIP OF THE DILATOR WAS ALLEGEDLY FOUND TO BE RUSTED AT THE TEAR. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569911 ↗
• MalfunctionJan 24, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE VIA THE LEFT FEMORAL ACCESS, WHEN ATTEMPTED TO RETRACT THE BALLOON INTO THE SHEATH, THE BALLOON WAS CAUGHT ON THE TIP OF THE SHEATH AND ALLEGEDLY COULD NOT BE REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569817 ↗
• MalfunctionJan 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING PREPARATION FOR A RECANALIZATION PROCEDURE, THE TIP OF THE DEVICE ALLEGEDLY CRACKED AND BECAME UNUSABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461819 ↗
• MalfunctionNov 27, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PREPARATION OF A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY THROUGH THE IPSILATERAL APPROACH, THE HEMOSTATIC VALVE OF THE DEVICE ALLEGEDLY DID NOT FIT PROPERLY AND WAS EASILY DISLODGED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213730 ↗