Halo One™ Thin-Walled Guiding Sheath HLO51035Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741161889), received between Dec 16, 2021 and Sep 11, 2026 — classified as 1 injury, 8 malfunctions.

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

• MalfunctionSep 11, 2026Failure to Advance; Detachment of Device or Device Component; Material Deformation

  On (b)(6) 2026, a patient underwent a recanalization procedure using a Halo One device. It was reported that, during the procedure, the healthcare professional had difficulty inserting the 5 to 10 from the same side. After four or five attempts, the tip became frayed and unusable. There was a part of the sheath that detached. The procedure was completed using another device. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728539 ↗
• MalfunctionMay 23, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  ON (B)(6) 2025, A PATIENT WAS UNDERGOING A RECANALIZATION PROCEDURE USING HALO ONE SHEATH. DURING THE PROCEDURE, WHEN ATTEMPTING TO INSERT THE PRODUCT INTO THE IPSILATERAL COMMON FEMORAL ARTERY IN A CASE OF CALCIFICATION, RESISTANCE WAS ENCOUNTERED AND INSERTION INTO THE BLOOD VESSEL WAS NOT POSSIBLE. THE PRODUCT WAS REMOVED FROM THE BODY AND THE TIP WAS FOUND TO BE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078458 ↗
• InjuryJan 10, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, IT WAS ALLEGEDLY DIFFICULT TO BE PUNCTURED AND INSERT THE SHEATH. IT WAS FURTHER REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED MORE BLEEDING THAN USUAL. REPORTEDLY, THE BLEEDING DID NOT STOP EASILY, AFTER USING THE HEMOSTATIC DEVICE AND THE BLOOD PRESSURE DROPPED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21122654 ↗
• MalfunctionDec 24, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE INTRODUCER SHEATH ALLEGEDLY COULD NOT BE INSERTED. IT WAS FURTHER REPORTED THAT THE TIP OF THE INTRODUCER SHEATH WAS ALLEGEDLY DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21010202 ↗
• 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. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20491020 ↗
• MalfunctionMar 5, 2024Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERIOR FEMORAL ARTERY VIA AN IPSILATERAL ANTEGRADE APPROACH, THE DEVICE SHEATH ITSELF STOPPED THE BLEEDING AND THE VALVE CONNECTION HAD ALLEGEDLY CAME LOOSE. IT WAS FURTHER REPORTED THAT THE SCREW THREAD ON THE SHEATH SIDE WAS ALLEGEDLY CRUSHED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18843091 ↗
• MalfunctionMay 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION, THE SHEATH WAS ALLEGEDLY FOUND TO BE TORN WHEN THE PHYSICIAN NOTICED THAT THE ABNORMAL FORM OF SHEATH UNDER FLUOROSCOPY AND REMOVED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885594 ↗
• MalfunctionDec 13, 2022Unraveled Material; Material Split, Cut or Torn; Unraveled Material; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION OF A RECANALIZATION PROCEDURE, THE TIP OF THE SHEATH WAS ALLEGEDLY FOUND PEELED UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15966550 ↗
• MalfunctionDec 16, 2021Unraveled Material; Device-Device Incompatibility; Material Deformation; Unraveled Material; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE SHEATH WAS ALLEGEDLY HARD TO BE INSERTED OVER THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE TIP OF THE SHEATH WAS FOUND TO BE ALLEGEDLY DAMAGED AND PEELED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13015678 ↗