Halo One™ Thin-Walled Guiding Sheath HLO54535Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00801741161926), received between Jul 15, 2020 and Apr 7, 2026 — classified as 60 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (28 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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Material Deformation; Material Split, Cut or Torn

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE VIA USING HALO ONE. DURING THE PROCEDURE, THE DILATOR REPORTEDLY HAD A TEAR AT THE TIP, WHICH ALLOWED THE GUIDEWIRE TO PASS THROUGH AND PREVENT ADVANCEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796534 ↗
• MalfunctionJun 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2025 A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING THE HALO DEVICE. DURING THE CROSSOVER TEST, THE WIRE TORE THE DILATOR WAS ALLEGEDLY SPLIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182638 ↗
• MalfunctionApr 3, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE TIP OF THE SHEATH BECAME FRAYED DUE TO CALCIFICATION OF THE PUNCTURE SITE AND HAD TO BE REINSERTED MANY TIMES. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760335 ↗
• MalfunctionMar 26, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA IPSILATERAL APPROACH, THE INTRODUCER SHEATH TIP WAS ALLEGEDLY DAMAGED DUE TO CALCIFICATION. IT WAS FURTHER REPORTED THAT THE INTRODUCER SHEATH WAS ALLEGEDLY DIFFICULT TO INSERT INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695175 ↗
• MalfunctionFeb 26, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE PUNCTURE SITE WAS HARD, AND THE TIP OF THE SHEATH WAS ROLLED UP AND COULD NOT BE USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466617 ↗
• MalfunctionFeb 5, 2025Missing Information; Missing Information

  IT WAS REPORTED THAT PRIOR TO A RECANALIZATION PROCEDURE, THE PRINT AT THE TOP OF THE PACKAGE, WHICH NORMALLY SHOWS THE FR NUMBER, WAS BLACKED OUT, SO THAT THE SIZE WAS ALLEGEDLY NO LONGER VISIBLE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312709 ↗
• MalfunctionDec 25, 2024Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE TIP OF THE INTRODUCER SHEATH ALLEGEDLY SPLIT VERTICALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21014659 ↗
• MalfunctionNov 26, 2024Failure 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 RECANALIZATION PROCEDURE, THE INTRODUCER SHEATH ALLEGEDLY COULD NOT BE INSERTED. IT WAS FURTHER REPORTED THAT THE DILATOR OF THE INTRODUCER SHEATH ALLEGEDLY SLIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786568 ↗
• MalfunctionNov 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, WHEN INSERTING THE SHEATH THE TIP ALLEGEDLY CURLED UP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20597032 ↗
• MalfunctionSep 23, 2024Failure 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 RECANALIZATION PROCEDURE, THE INTRODUCER SHEATH ALLEGEDLY COULD NOT PASS THROUGH THE BIFURCATION. IT WAS FURTHER REPORTED THAT UPON REMOVAL OF THE DILATOR, IT WAS ALLEGEDLY FOUND TO BE CRACKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20277197 ↗
• MalfunctionJul 5, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE BELOW KNEE LESION VIA AN IPSILATERAL APPROACH, THE TIP END POINT OF THE INTRODUCER SHEATH WAS ALLEGEDLY TURNED UP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19677568 ↗
• MalfunctionJun 17, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE TREATMENT OF BELOW KNEE AREA, THE TIP WAS ALLEGEDLY KINKED AND COULD NOT BE INSERTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19545635 ↗
• MalfunctionJun 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE DILATOR WAS ALLEGEDLY SHEARED AND SPLIT IN TWO. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508491 ↗
• MalfunctionJun 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING THE PREPARATION OF A RECANALIZATION PROCEDURE, A WHITE-COLORED STAIN-LIKE SUBSTANCE, WHICH APPEARED TO BE A COATING AGENT, WAS ALLEGEDLY FOUND ADHERING NEAR THE TIP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458481 ↗
• MalfunctionJan 17, 2024Material Deformation; Material Split, Cut or Torn; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE DILATOR WAS ALLEGEDLY FOUND TO HAVE A SPLIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18523590 ↗
• MalfunctionJul 10, 2023Peeled/Delaminated; Failure to Advance; Peeled/Delaminated; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE TIP OF THE SHEATH WAS ALLEGEDLY FRAYED. IT WAS FURTHER REPORTED THE SHEATH ALLEGEDLY FAILED TO INSERT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17285072 ↗
• MalfunctionJun 13, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE COATING OF THE SHEATH ALLEGEDLY PEELED OFF WHEN THE SHEATH WAS WETTED WITH SALINE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117104 ↗
• MalfunctionMay 9, 2023Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A HIGHLY CALCIFIED TARGET LESION VIA A CONTRALATERAL APPROACH, THE TIP OF THE SHEATH WAS ALLEGEDLY PEELED OFF AND TORN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16893752 ↗
• MalfunctionFeb 16, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING THE PREPARATION OF AN ANGIOPLASTY PROCEDURE, THE COATED PART OF THE GUIDING SHEATH DEVICE WAS ALLEGEDLY FOUND TO HAVE CONTAMINATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385179 ↗
• MalfunctionJan 20, 2023Unraveled Material; Device Contamination with Chemical or Other Material; Unraveled Material; Device Contamination with Chemical or Other Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213229 ↗
• MalfunctionJan 4, 2023Peeled/Delaminated; Failure to Advance; Peeled/Delaminated; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE COATING OF THE SHEATH WAS ALLEGEDLY FOUND PEELED OFF AND FAILED TO BE INSERTED. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16092808 ↗
• MalfunctionDec 19, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE VIA AN IPSILATERAL ANTEGRADE APPROACH, THE TIP OF THE SHEATH WAS ALLEGEDLY FOUND SPLIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16002521 ↗
• MalfunctionDec 7, 2022Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE ILIAC ARTERY VIA A CONTRALATERAL APPROACH, THERE WAS STRONG RESISTANCE FELT AT THE BIFURCATION OF THE ILIAC ARTERY. IT WAS FURTHER REPORTED THAT THE SHEATH WAS ALLEGEDLY FOUND TO BE SPLIT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15930202 ↗
• MalfunctionNov 1, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PREPARATION OF A RECANALIZATION PROCEDURE, THE LUER LOCK WAS ALLEGEDLY DOES NOT HOLD THE VALVE AND THE SHAFT TOGETHER AND, ALLEGEDLY OPEN AGAIN WHEN TIGHTENED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15706263 ↗
• MalfunctionOct 18, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THERE WAS STICKINESS FELT ON THE SHAFT OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15622620 ↗