Halo One™ Thin-Walled Guiding Sheath HAL545Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741111549), received between Jul 26, 2016 and Jul 26, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Dec 2, 2016Class ITerminated

   Complaints of sheath separation, kinking, and/or tip damage during use.

   Z-0968-2017 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2016Break

  IT WAS REPORTED THAT THE GUIDING SHEATH BROKE INTO TWO SEGMENTS. THERE WERE NO ANOMALIES NOTED DURING THE PREP OF THE DEVICE. THERE AS NO DAMAGE NOTED TO THE PACKAGING. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT WAS BEING TREATED FOR STENOSIS. A CSI AND BARD ULTRAVERSE 5X300 .018 BALLOON DEVICE WERE USED. THE DILATOR WAS USED TO PLACE AND RE-POSITION THE SHEATH AT ALL TIMES. WHILE REMOVING THE HALO 45CM AFTER A SUCCESSFUL PERIPHERAL INTERVENTION THE GUIDING HEATH BROKE INTO TWO PIECES. THE DEVICE WAS REMOVED OVER THE HALO AND THE HALO SHEATH BROKE IN MIDDLE ABOUT 20CM FROM THE VALVE AND AT THE TIP WHEN BEING REMOVED. FORTUNATELY THE TIP WAS NOT LEFT IN THE PATIENT . THE DEVICE WAS REMOVED AND THERE WAS NO INCIDENT TO THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5821729 ↗
• MalfunctionJul 26, 2016Kinked

  IT WAS REPORTED THAT THE DEVICE KINKED/UNRAVELLED AND THE GUIDEWIRE PIERCED THROUGH THE SHEATH. THERE WERE NO ANOMALIES NOTED DURING THE PREP OF THE DEVICE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE INTENDED TREATMENT SITE WAS THE RIGHT SFA. THE PATIENT WAS BEING TREATED TO DIFFUSE DISEASE IN THE RIGHT SFA TO POPLITEAL. THE VESSEL AND TRACKING PATH WAS NOT CALCIFIC OR TORTUOUS. IT WAS A NORMAL BIFURCATION. A CONTRALATERAL APPROACH WAS MADE. A 035 TERUMO GLIDEWIRE WAS USED AND THIS WAS KEPT HYDRATED AT ALL TIMES. THE SHEATH WAS ADVANCED SMOOTHLY WHILE TRACKING OVER THE WIRE. THE DEVICE ALLEGEDLY KINKED/UNRAVELLED WHEN CONTRALATERAL ACCESS WAS GAINED AND WIRE AND DILATOR WERE REMOVED FOR ANGIOGRAM. IT WAS FURTHER REPORTED THAT THE WIRE PIERCED THOUGH THE SHEATH. THE SHEATH WAS REMOVED FROM THE PATIENT. A SECOND ACCESS SITE WAS MADE TO CHECK FOR VESSEL PERFORATION. REPORTEDLY, THE VESSEL LOOKED GOOD. NO DEVICES WERE USED WIT THE SHEATH AS THE SHEATH KINKED BEFORE STARTING THE PROCEDURE. THE SHEATH OR DILATOR DID NOT BREAK OR DETACH AT ANY TIME DURING THE PROCEDURE. THE SHEATH WAS PROTECTED BY THE DILATOR AT ALL TIMES DURING ALL STEPS OF TRACKING TO THE TARGET LESION. THE GUIDEWI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5821727 ↗