Halo One™ Thin-Walled Guiding Sheath HLO61035FRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741161964), received between Mar 17, 2021 and Mar 31, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Failure to Advance; Material Deformation

  ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING HALO ONE. DURING THE PROCEDURE THERE WAS NO SUCTION AFTER TWO RUNS. IT WAS REPORTED THAT SHEATH WRINKLED AT THE TIP UPON INSERTION INTO PATIENT. INSERTION OF SHEATH WAS WITH DILATOR INSTALLED. BECAUSE OF THE WRINKLES AT THE TIP, IT WAS NOT POSSIBLE TO FULLY INSERT THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741194 ↗
• MalfunctionOct 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DILATOR WAS ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026642 ↗
• MalfunctionFeb 3, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE TO TREAT STENOSIS, THE LUER LOCK WAS NOT POSSIBLE TO CONNECT TIGHTLY AND THE SHEATH ALLEGEDLY KEPT OPENING BY ITSELF. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13442501 ↗
• MalfunctionAug 23, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE LUER LOCK CONNECTION ALLEGEDLY CAME LOOSE AND THE SHEATH OPENS BY ITSELF . THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352853 ↗
• MalfunctionAug 11, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE LUER-LOCK CONNECTOR WAS ALLEGEDLY LOOSENED AND THE ENTIRE HEMOSTATIC VALVE DISCONNECTED WHEN THE PHYSICIAN PULLED OUT THE SHAFT FROM THE STENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307119 ↗
• 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 WAS OPENED BY ITS OWN AND THE PATIENT EXPERIENCED 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 11525761 ↗
• InjuryMar 17, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LUER LOCK CANNOT BE PROPERLY CONNECTED. IT WAS REPORTED THAT THE SHEATH WAS OPENED BY ITS OWN AND THE PATIENT EXPERIENCED 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 11504513 ↗