Halo One™ Thin-Walled Guiding Sheath HLO62535HRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00801741184871), received between Jun 3, 2021 and Aug 31, 2026 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (24 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.

• MalfunctionAug 31, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50523219 ↗
• MalfunctionMar 17, 2026Difficult to Insert; Material Split, Cut or Torn

  ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE UTILIZING THE HALO ONE DEVICE. DURING THE PROCEDURE A CRACK WAS OBSERVED AT THE TIP OF THE DILATOR, RESULTING IN INCREASED DIFFICULTY DURING INSERTION. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING AN ALTERNATIVE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615308 ↗
• MalfunctionJan 5, 2026Failure to Advance; Material Deformation; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT RECANALIZATION PROCEDURE USING HALO ONE DEVICE. IT WAS REPORTED THAT ATTEMPTED TO INSERT THE DILATOR VIA THE IPSILATERAL APPROACH, BUT INSERTION WAS IMPOSSIBLE AND THE DILATOR BEGAN TO TEAR. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955551 ↗
• MalfunctionJan 2, 2026Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THROUGH THE HALO ONE DEVICE. PRIOR TO PROCEDURE, IT WAS REPORTED THAT THE TIP, SPECIFICALLY THE END POINT OF THE INNER CATHETER, WAS FOUND TO BE SPLIT. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23941436 ↗
• MalfunctionOct 24, 2025Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT ANGIOPLASTY PROCEDURE USING A HALO ONE DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE INTRODUCER SHEATH WAS ALLEGEDLY DAMAGED. IT WAS FURTHER REPORTED THAT A DIFFERENT SHEATH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377967 ↗
• MalfunctionOct 16, 2025Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE THROUGH IPSILARETAL FEMORAL APPROACH FOR SFA STENOSIS. ALLEGEDLY THE SHEATH WAS IMPOSSIBLE TO INSERT CAUSED BY INSERTION RESISTANCE AND ALLEGEDLY THERE WAS SPLIT ON THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308537 ↗
• MalfunctionJul 14, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE HALO DEVICE, THE DEVICE ALLEGEDLY FAILED TO INSERT INTO THE SAME SIDE SFA. THE TIP WAS ALLEGEDLY FOUND TO BE FRAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492398 ↗
• MalfunctionJul 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE HALO ONE DEVICE AND PRIOR TO THE PROCEDURE A CRACK WAS FOUND AT THE TIP OF THE DILATOR WHEN THE PRODUCT WAS OPENED. THE PROCEDURE WAS CARRIED OUT AFTER CHANGING TO A DIFFERENT SHEATH. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410831 ↗
• MalfunctionMay 26, 2025Unraveled Material; Unraveled Material

  ON (B)(6) 2025, A PATIENT WAS UNDERGOING A RECANALIZATION PROCEDURE, FOR AN UNKNOWN MEDICAL CONDITION. IT WAS REPORTED THAT, DURING THE PROCEDURE, THE SHEATH COATING ALLEGEDLY CAME OFF DURING THE PUNCTURE. THE SHEATH WAS REMOVED AND THE PUNCTURE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22082999 ↗
• MalfunctionMay 19, 2025Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  ON 21-APR-2025, THE PATIENT UNDERWENT SUPERFICIAL FEMORAL ARTERY STENOSIS VIS IPSILATERAL ANTEGRADE LESION, THEY INSERT THE SERGEANT 014 90 CM + DILATOR + THIS PRODUCT INTO THE 014 GW THAT REMAINED IN THE BODY. BUT IT DID NOT ENTER THE BODY EASILY, AND UPON CHECKING THE TIP, THE DILATOR WAS FOUND TO HAVE BEEN DAMAGED WITH A LARGE TEAR. THE PROCEDURE WAS COMPLETED BY USING A SEPARATE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22043348 ↗
• MalfunctionMay 19, 2025Device Dislodged or Dislocated; Material Split, Cut or Torn; Device Dislodged or Dislocated; Material Split, Cut or Torn

  ON (B)(6) 2025, THE PATIENT UNDERWENT SFA STENOSIS VIS IPSILATERAL ANTEGRADE LESION, 035 GW WAS INSERTED ONCE AND THE PROCEDURE PROCEEDED, BUT ALLEGEDLY PATIENT MOVED TOWARDS THE END AND THE PRODUCT WHICH HAD BEEN ABOUT HALF-INSERTED, FELL OUT OF THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041669 ↗
• MalfunctionMay 9, 2025Difficult to Insert; Failure to Advance; Material Deformation; Material Split, Cut or Torn; Difficult to Insert; Failure to Advance; Material Deformation; Material Split, Cut or Torn

  ON (B)(6) 2025, A PATIENT WAS UNDERGOING AN ANGIOPLASTY PROCEDURE, USING THE HALO DEVICE VIA IPSILATERAL TO THE SFA LESION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SHEATH COULD NOT BE INSERTED. THE SHEATH WAS REMOVED FROM THE BODY, IT WAS FURTHER REPORTED THAT, THE TIP WAS FOUND TO BE CRACKED. ANOTHER IDENTICAL PRODUCT WAS INSERTED WITHOUT ANY DIFFICULTY AND THE PROCEDURE WAS COMPLETED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21991356 ↗
• MalfunctionApr 25, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A HALO ONE PROCEDURE IN AN IPSILATERAL CIRCUMFERENTIAL MANNER. AN ATTEMPT WAS MADE TO INSERT THE SHEATH BUT SEVERE CALCIFICATION MADE INSERTION DIFFICULT. AFTER REMOVING THE SHEATH FROM THE PATIENT'S BODY, IT WAS FOUND THAT THE TIP OF THE SHEATH WAS ALLEGEDLY DAMAGED, SO WE ATTEMPTED TO INSERT A NEW SHEATH, WHICH WAS SUCCESSFULLY INSERTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21906494 ↗
• MalfunctionApr 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE TIP OF THE SHEATH WAS ALLEGEDLY CURLED UP DUE TO CALCIFICATION AT THE PUNCTURE SITE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760110 ↗
• MalfunctionMar 17, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE TIP WAS ALLEGEDLY DEFORMED WHILE INSERTING THE SHEATH. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO INSERT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21616932 ↗
• MalfunctionDec 12, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED DURING A RECANALIZATION PROCEDURE, THE INTRODUCER SHEATH ALLEGEDLY BROKE DUE TO CALCIFICATION. IT WAS FURTHER REPORTED THAT THE INTRODUCER SHEATH ALLEGEDLY KINKED. THE PROCEDURE WAS COMPLETED USING DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20910324 ↗
• InjuryNov 12, 2024Difficult to Insert; Failure to Advance; Material Split, Cut or Torn; Difficult to Insert; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE INTRODUCER SHEATH ALLEGEDLY DID NOT ADVANCE BEYOND FOUR CENTIMETERS FROM THE TIP. IT WAS FURTHER REPORTED THAT THE TIP OF THE SHEATH ALLEGEDLY HAD TWO CENTIMETERS BREAK IN THE DILATOR. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE FROM DIFFERENT MANUFACTURER. FURTHERMORE, IT WAS REPORTED THAT THE ARTERY NEAR THE PUNCTURE SITE ALLEGEDLY EXPERIENCED BLEEDING AND THE PATIENT PRESENTED WITH SWELLING AND COMPLAINED ABOUT PAIN. REPORTEDLY, AN APPROXIMATION OF SIX HOURS AFTER INITIAL TREATMENT, AN ENDOVASCULAR THROMBECTOMY WAS REPEATED AND BOTH A STENT GRAFT AND STENT WERE PLACED NEAR THE BLEEDING SITE. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 20665110 ↗
• MalfunctionOct 22, 2024Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, 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 20503120 ↗
• MalfunctionSep 27, 2024Break; Failure to Advance; Material Deformation; Material Split, Cut or Torn; Break; Failure to Advance; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE TIP OF THE INTRODUCER SHEATH ALLEGEDLY CURLED UP. IT WAS FURTHER REPORTED THAT ALLEGEDLY THERE WAS LOT OF RESISTANCE WHILE INSERTING THE SHEATH. FURTHERMORE, IT WAS REPORTED THAT THE DILATOR 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 20319308 ↗
• MalfunctionSep 16, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE HEMOSTATIC VALVE ALLEGEDLY COULD NOT BE FIXED AFTER OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20222767 ↗
• MalfunctionSep 6, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE TIP OF THE INTRODUCER SHEATH ALLEGEDLY CURLED UP DUE TO THE CALCIFICATION WHEN INSERTED IT, MAKING IT ALLEGEDLY DIFFICULT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20155198 ↗
• MalfunctionJul 30, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE INTRODUCER SHEATH ALLEGEDLY COULD NOT BE REINSERTED AS THE TIP WAS ALLEGEDLY FOUND TO BE DEFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19859376 ↗
• MalfunctionJul 17, 2024Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19759282 ↗
• MalfunctionFeb 5, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE HEMOSTATIC VALVE ALLEGEDLY DID NOT LOCK AND CAME OFF WHICH MADE IT IMPOSSIBLE TO FIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18638118 ↗
• MalfunctionNov 15, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE HEMOSTATIC VALVE WAS ALLEGEDLY NOT LOCKED. IT WAS FURTHER REPORTED THAT THE VALVE CAME OFF AND WAS MAKING IT IMPOSSIBLE TO ATTACH WITH THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138077 ↗