Halo One Thin-Walled Guiding Sheath HLO64535Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00801741223877), received between Mar 23, 2022 and Sep 29, 2026 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (18 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Deformation

  On (b)(6) 2026, a patient underwent a recanalization procedure using a Halo One device in the superficial femoral artery via a contralateral approach. During the procedure, calcification at the access site resulted in deformation of the sheath tip, causing it to curl and rendering the device unusable. Upon inspection, damage to the sheath tip was observed. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930858 ↗
• MalfunctionSep 29, 2026Failure to Advance; Material Deformation; Material Split, Cut or Torn

  On (b)(6)2026, a patient underwent a recanalization procedure for stenosis via superficial femoral artery using a Halo One device. During the procedure, the sheath became kinked. Additionally, it was reported that upon entering the puncture site, some resistance was felt. The procedure was completed using another device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929910 ↗
• MalfunctionAug 4, 2026Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Advance; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50126744 ↗
• MalfunctionNov 13, 2025Difficult to Insert; Peeled/Delaminated; Material Deformation; Difficult to Insert; Peeled/Delaminated; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT RECANALIZATION PROCEDURE USING HALO ONE FOR SFA AND POP LESIONS USING THE SAME ANTEGRADE APPROACH. DURING PROCEDURE, WHEN INITIALLY SWITCHING FROM A 4F SHORT SHEATH TO THE PRODUCT, THERE WAS POOR INSERTION AND THERE WAS A SUSPECTED PRODUCT COATING PEEL OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539967 ↗
• MalfunctionJun 19, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  ON (B)(6) 2024, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE HALO DEVICE. DURING PROCEDURE WHILE INSERTING THE SHEATH, THE TIP END POINT WAS WISPY, FRAYED AND IT WAS NOT POSSIBLE TO INSERT IT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22291223 ↗
• MalfunctionApr 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE SHEATH ALLEGEDLY TORN. IT WAS FURTHER REPORTED THAT THE DILATATOR TORE OPEN THE SHEATH WITH THE WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21823502 ↗
• InjuryApr 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THERE WAS A EXTRAVASAL HEMATOMA JUST ABOVE THE AORTIC BIFURCATION ON THE LEFT, CONSISTENT WITH A PERFORATION OF THE AORTA. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 21803479 ↗
• MalfunctionApr 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN SUPERFICIAL FEMORAL ARTERY, THE TIP OF THE SHEATH WAS ALLEGEDLY TURNED UP DUE TO A CALCIFIED LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21783428 ↗
• MalfunctionMar 4, 2025Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE COMMON FEMORAL ARTERY VIA CONTRALATERAL APPROACH, THE INTRODUCER SHEATH ALLEGEDLY KINKED AND DID NOT PASS THROUGH THE LESION. IT WAS FURTHER REPORTED THAT THE INTRODUCER SHEATH ALLEGEDLY BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21512407 ↗
• MalfunctionFeb 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE DILATOR ALLEGEDLY CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21429732 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THERE WAS ALLEGEDLY AN EXTRAVASAL HEMATOMA JUST ABOVE THE AORTIC BIFURCATION ON THE LEFT, CONSISTENT WITH A PERFORATION OF THE AORTA. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 21400333 ↗
• MalfunctionNov 5, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE INTRODUCER SHEATH ALLEGEDLY WOULD NOT TIGHTEN TOGETHER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608336 ↗
• MalfunctionOct 21, 2024Device-Device Incompatibility; Material Deformation; Material Split, Cut or Torn; Device-Device Incompatibility; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO INSERT THROUGH THE SHEATH AND STUCK IN THE PROXIMAL PORTION OF THE SHEATH. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE EITHER ALLEGEDLY KINKED OR HAD SOMETHING WEIRD WITH THE ENTRY PORT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490782 ↗
• MalfunctionOct 11, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED DURING A RECANALIZATION PROCEDURE, THE INTRODUCER SHEATH ALLEGEDLY BROKE WITH A KINK SHEATH. IT WAS FURTHER REPORTED THAT THE INTRODUCER SHEATH ALLEGEDLY KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20425535 ↗
• MalfunctionSep 16, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE VIA THE CONTRALATERAL APPROACH, THE INTRODUCER SHEATH ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE SHEATH ALLEGEDLY BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20221877 ↗
• MalfunctionSep 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY VIA THE UP AND OVER APPROACH, ONE-THIRD OF THE DISTAL PART OF THE SHEATH WAS ALLEGEDLY FLAT IN APPEARANCE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20133242 ↗
• MalfunctionAug 26, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY STENOSIS VIA THE CONTRALATERAL APPROACH, THE INTRODUCER SHEATH WAS ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE INTRODUCER SHEATH WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062926 ↗
• MalfunctionJun 26, 2024Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE SHEATH ALLEGEDLY SPLIT WHEN PUSHED FORWARD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19612844 ↗
• MalfunctionJun 11, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE HYDROPHILIC COATING WAS ALLEGEDLY PEELED OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508216 ↗
• MalfunctionMay 25, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE IN THE RIGHT ANTERIOR TIBIAL ARTERY, WHEN THE BOX WAS OPENED AND THE PRODUCT WAS REMOVED FROM THE BOX, THE DILATOR WAS ALLEGEDLY FOUND TO BE KINKED. IT WAS FURTHER REPORTED THAT THE DILATOR PORTION WAS ALLEGEDLY BROKEN OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398156 ↗
• MalfunctionJan 12, 2024Retraction Problem; Material Deformation; Retraction Problem; Material Deformation

  IT WAS REPORTED THAT DURING THE RECANALIZATION PROCEDURE, THE TIP OF THE RECANALIZATION CATHETER ALLEGEDLY WOULD NOT PULL BACK THROUGH THE SHEATH. THE SHEATH AND THE RECANALIZATION CATHETER WAS ALLEGEDLY REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501133 ↗
• MalfunctionDec 29, 2023Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, SHEATH ALLEGEDLY GOT TWISTED. REPORTEDLY, THE SHEATH WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18417158 ↗
• MalfunctionAug 17, 2023Peeled/Delaminated; Device Contamination with Chemical or Other Material; Peeled/Delaminated; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, WHEN WIPING THE SHEATH WITH A WET GAUZE WHILE PREPPING, IT WAS NOTICED THAT THE HYDROPHILIC COATING ALLEGEDLY CAME OFF AND TURNED TO GEL WHEN IT GOT WET. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563520 ↗
• InjuryApr 21, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE SHEATH WAS ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT DISSECTION WAS NOTICED IN THE COMMON FEMORAL AND PROXIMAL SFA. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THE PATIENT REPORTED TO BE STABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14167218 ↗
• InjuryMar 23, 2022Failure to Advance; Material Deformation; Material Split, Cut or Torn; Failure to Advance; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE VIA RENAL INTERVENTION OF A CALCIFIC LESION IN THE RIGHT SFA THROUGH A CONTRALATERAL LEFT APPROACH, RESISTANCE WAS ALLEGEDLY MET AND THE DEVICE FAILED TO ADVANCE. IT WAS FURTHER REPORTED THAT UPON REMOVAL, THE INTRODUCER WAS NOTED TO BE DAMAGED. AN ACCESS WAS GAINED FROM THE OPPOSITE SIDE AND THE DEVICE WAS RECOVERED OFF THE PATIENT. THE PATIENT WAS REPORTED TO BE IN A STABLE CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13868758 ↗