Halo One Thin-Walled Guiding SheathRecalls & reported problems across all models
Clearstream Technologies Limited · 27 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 281
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 3
We found 27 models of Halo One Thin-Walled Guiding Sheath by Clearstream Technologies Limited in the FDA's device registry (GUDID). Together they are named in 281 adverse event reports in the FDA's MAUDE database, received between Jul 26, 2016 and Sep 29, 2026 — classified as 16 injuries, 265 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (139 reports).
3 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Halo One Thin-Walled Guiding Sheath recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 2, 2016Terminated
Complaints of sheath separation, kinking, and/or tip damage during use.
Z-0970-2017 · Root cause: Device Design · Recall details · FDA record ↗
- Dec 2, 2016Terminated
Complaints of sheath separation, kinking, and/or tip damage during use.
Z-0969-2017 · Root cause: Device Design · Recall details · FDA record ↗
- Dec 2, 2016Terminated
Complaints of sheath separation, kinking, and/or tip damage during use.
Z-0968-2017 · Root cause: Device Design · Recall details · FDA record ↗
Most reported Halo One Thin-Walled Guiding Sheath problems
Device problems
- Material Deformation139
- Material Split, Cut or Torn73
- Failure to Advance72
- Difficult to Insert39
- Connection Problem30
- Unraveled Material25
- Device Contamination with Chemical or Other Material22
- Break17
Patient problems
- No Clinical Signs, Symptoms or Conditions263
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Hemorrhage/Blood Loss/Bleeding6
- Hematoma3
- No Consequences Or Impact To Patient3
- Perforation3
- No Known Impact Or Consequence To Patient2
- Pain2
Halo One Thin-Walled Guiding Sheath models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Halo One™ Thin-Walled Guiding Sheath HLO54535INTRODUCER, CATHETER60 reports
- Halo One™ Thin-Walled Guiding Sheath HAL545INTRODUCER, CATHETER1 recall2 reports
- Halo One™ Thin-Walled Guiding Sheath HAL590INTRODUCER, CATHETER1 recall0 reports
- Halo One™ Thin-Walled Guiding Sheath HAL510FINTRODUCER, CATHETER1 recall0 reports
- Halo One™ Thin-Walled Guiding Sheath HLO61035INTRODUCER, CATHETER45 reports
- Halo One™ Thin-Walled Guiding Sheath HLO62535HINTRODUCER, CATHETER45 reports
- Halo One Thin-Walled Guiding Sheath HLO64535INTRODUCER, CATHETER25 reports
- Halo One™ Thin-Walled Guiding Sheath HLO52535HINTRODUCER, CATHETER16 reports
- Halo One™ Thin-Walled Guiding Sheath HLO59035INTRODUCER, CATHETER14 reports
- Halo One Thin-Walled Guiding Sheath HLO69035INTRODUCER, CATHETER11 reports
- Halo One™ Thin-Walled Guiding Sheath HLO51035FINTRODUCER, CATHETER10 reports
- Halo One™ Thin-Walled Guiding Sheath HLO51035INTRODUCER, CATHETER9 reports
- Halo One™ Thin-Walled Guiding Sheath HLO44535INTRODUCER, CATHETER8 reports
- Halo One™ Thin-Walled Guiding Sheath HLO61035FINTRODUCER, CATHETER7 reports
- Halo One™ Thin-Walled Guiding Sheath HLO57035INTRODUCER, CATHETER5 reports
- Halo One™ Thin-Walled Guiding Sheath HLO41035FINTRODUCER, CATHETER4 reports
- Halo One™ Thin-Walled Guiding Sheath HLO42535HINTRODUCER, CATHETER4 reports
- Halo One Thin-Walled Guiding Sheath HLO67035INTRODUCER, CATHETER3 reports
- Halo One™ Thin-Walled Guiding Sheath HLO41035INTRODUCER, CATHETER2 reports
- Halo One™ Thin-Walled Guiding Sheath HLO49035INTRODUCER, CATHETER2 reports
- Halo One™ Thin-Walled Guiding Sheath HLO41018FHINTRODUCER, CATHETER2 reports
- Halo One Thin-Walled Guiding Sheath HLO62535HKIntroducer, catheter2 reports
- Halo One™ Thin-Walled Guiding Sheath HLO47035INTRODUCER, CATHETER1 report
- Halo One™ Thin-Walled Guiding Sheath HLO62535INTRODUCER, CATHETER1 report
- Halo One™ Thin-Walled Guiding Sheath HLO41035FHINTRODUCER, CATHETER1 report
- Halo One Thin-Walled Guiding Sheath HLO52535HKIntroducer, catheter1 report
- Halo One Thin-Walled Guiding Sheath HLO61035FHKIntroducer, catheter1 report
Recent Halo One Thin-Walled Guiding Sheath adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Deformation
On (b)(6) 2026, a patient underwent a recanalization procedure using a Halo One device in the superficial femoral artery via a contralateral approach. During the procedure, calcification at the access site resulted in deformation of the sheath tip, causing it to curl and rendering the device unusable. Upon inspection, damage to the sheath tip was observed. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930858 ↗MalfunctionSep 29, 2026Failure to Advance; Material Deformation; Material Split, Cut or Torn
On (b)(6)2026, a patient underwent a recanalization procedure for stenosis via superficial femoral artery using a Halo One device. During the procedure, the sheath became kinked. Additionally, it was reported that upon entering the puncture site, some resistance was felt. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929910 ↗MalfunctionSep 25, 2026Connection Problem
On(b)(6) 2026, a patient underwent recanalization procedure using a Halo One device. It was reported that before use the hemostatic valve cannot be screwed onto the sheath. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895115 ↗MalfunctionSep 11, 2026Failure to Advance; Detachment of Device or Device Component; Material Deformation
On (b)(6) 2026, a patient underwent a recanalization procedure using a Halo One device. It was reported that, during the procedure, the healthcare professional had difficulty inserting the 5 to 10 from the same side. After four or five attempts, the tip became frayed and unusable. There was a part of the sheath that detached. The procedure was completed using another device. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728539 ↗MalfunctionSep 8, 2026Material Deformation
On (b)(6) 2026, a patient underwent a recanalization procedure for ipsilateral SFA treatment using a Halo One device. During the procedure, the tip of the sheath curled up, rendering it unusable. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667730 ↗MalfunctionAug 31, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50523219 ↗MalfunctionAug 4, 2026Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Advance; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50126744 ↗MalfunctionJul 28, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50050286 ↗MalfunctionJul 28, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50048804 ↗MalfunctionApr 13, 2026Material Deformation
ON (B)(6) 2026, A PATIENT UNDERWENT AN ANGIOPLASTY PROCEDURE USING HALO ONE DEVICE. DURING THE PROCEDURE, THE TIP OF THE SHEATH CURLED UP. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24854427 ↗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 ↗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 ↗MalfunctionMar 18, 2026Difficult to Insert; Material Deformation
ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE BY USING HALO ONE. IT WAS REPORTED THAT DURING PROCEDURE THE TIP ALLEGEDLY CURLED DURING SHEATH INSERTION CAUSES INSERTION DIFFICULTY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24625640 ↗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 ↗MalfunctionFeb 19, 2026Break; Material Deformation
ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE BY USING HALO ONE. IT WAS REPORTED THAT PRIOR TO USE IT WAS REPORTED THAT THE DILATOR LUER WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED DAMAGE TO THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385539 ↗
Other Clearstream Technologies Limited products
All Clearstream Technologies Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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