Halo One™ Thin-Walled Guiding Sheath HLO59035Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741161940), received between Mar 10, 2021 and Jan 9, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Difficult to Insert; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING HALO ONE. DURING THE PROCEDURE, THE WIRE ALLEGEDLY PUNCTURED, INSERTION ALONG THE WIRE. IT WAS FURTHER REPORTED THAT THE AORTIC ARCH CURVATURE WAS SEVERE, MAKING PASSING THROUGH DIFFICULT. FURTHERMORE, AFTER SEVERAL ATTEMPTS OF PUSHING AND PULLING, THE PORTION OUTSIDE THE BODY KINKED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016869 ↗
• MalfunctionOct 22, 2025Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  ON SEP 30, 2025, THERE WAS AN INTERNAL BD SPONSORED ANIMAL STUDY USING EXPIRED HALO ONE THIN-WALLED GUIDING SHEATHS. ONE OF THE SHEATHS USED HAD THE FOLLOWING MALFUNCTION: A PINHOLE IN THE DIAPHRAGM WAS PRESENT, ENABLING "NON-STOP" BLOOD FLOW. THE DEVICE HAS BEEN REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355231 ↗
• MalfunctionApr 7, 2025Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING RECANALIZATION PROCEDURE, THE SHEATH WOULD NOT ADVANCE INTO ARTERY. IT WAS FURTHER REPORTED THAT THE DILATOR ALLEGEDLY SPLIT AT THE TIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785259 ↗
• MalfunctionApr 7, 2025Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING RECANALIZATION PROCEDURE, THE SHEATH ALLEGEDLY DID NOT ADVANCE INTO ARTERY. IT WAS FURTHER REPORTED THAT THE DILATOR SPLIT AT THE TIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21783820 ↗
• MalfunctionApr 7, 2025Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING RECANALIZATION PROCEDURE, THE SHEATH ALLEGEDLY DID NOT ADVANCE INTO ARTERY. IT WAS FURTHER REPORTED THAT THE DILATOR SPLIT AT THE TIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21783818 ↗
• MalfunctionApr 7, 2025Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING RECANALIZATION PROCEDURE, THE SHEATH ALLEGEDLY DID NOT ADVANCE INTO ARTERY. IT WAS FURTHER REPORTED THAT THE DILATOR SPLIT AT THE TIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21783610 ↗
• MalfunctionOct 5, 2023Difficult to Insert; Material Deformation; Material Split, Cut or Torn; Difficult to Insert; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE RECANALIZATION PROCEDURE, THE SHEATH WAS ALLEGEDLY DIFFICULT TO INSERT. IT WAS FURTHER REPORTED THAT THE TIP OF THE SHEATH WAS ALLEGEDLY SHEARED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875603 ↗
• MalfunctionAug 25, 2023Peeled/Delaminated; Device Contamination with Chemical or Other Material; Peeled/Delaminated; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING A RECANALIZATION 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. IT WAS FURTHER REPORTED THAT THE GEL SUBSTANCE WAS WIPED OFF AND THE SHEATH WAS STILL USED WITH NO ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17621749 ↗
• MalfunctionApr 10, 2023Failure to Advance; Material Deformation; Material Split, Cut or Torn; Failure to Advance; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE CATHETER WAS ALLEGEDLY UNABLE TO ADVANCE THOUGH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708716 ↗
• MalfunctionOct 10, 2022Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY VIA A CONTRALATERAL APPROACH, THE SHEATH ALLEGEDLY FAILED TO BE INSERTED. IT WAS FURTHER REPORTED THAT TIP OF THE SHEATH WAS FOUND DAMAGED AFTER MULTIPLE INSERTION ATTEMPTS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15572346 ↗
• MalfunctionSep 27, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA A CONTRALATERAL APPROACH, THE BLOOD WAS ALLEGEDLY LEAKED FROM THE HEMOSTASIS VALVE IMMEDIATELY UPON THE SHEATH WAS INSERTED INTO THE VESSEL. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492802 ↗
• MalfunctionAug 5, 2022Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, INNER DILATOR OF THE SHEATH WAS ALLEGEDLY SPLIT WHILE ADVANCING IT DURING A PROCEDURE BEING ACCESSED RADIALLY. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY DIFFICULT TO INSERT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15173858 ↗
• MalfunctionJul 29, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY PROCEDURE, THE HEMOSTASIS VALVE ALLEGEDLY EXPERIENCED A CONNECTION PROBLEM. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127518 ↗
• MalfunctionMar 10, 2021Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, RESISTANCE WAS ALLEGEDLY FELT DURING ADVANCING OVER THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT A VISCOUS SUBSTANCE WAS FOUND ADHERED TO THE PHYSICIAN'S GLOVE AND A LARGE AMOUNT OF THE SAME GEL SUBSTANCE WAS IDENTIFIED AT THE INSERTION SITE AS WELL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11452404 ↗