Halo One™ Thin-Walled Guiding Sheath HAL510FRecalls & reported problems

Clearstream Technologies Limited · Halo One Thin-Walled Guiding Sheath 5F x 10cm · Class 2

All models of Halo One Thin-Walled Guiding Sheath (27)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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

Dec 2, 2016Class ITerminated
Complaints of sheath separation, kinking, and/or tip damage during use.
Z-0970-2017 · Root cause: Device Design · Recall details · FDA record ↗

Device details

UDI-DI	`00801741129698`
Brand	Halo One™ Thin-Walled Guiding Sheath
Model	HAL510F
Company	Clearstream Technologies Limited
Product code	DYB · INTRODUCER, CATHETER
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 22, 2021

Device type (GMDN): Vascular guide-catheter, single-use

A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Other INTRODUCER, CATHETER devices

VIZIGO D138502
Biosense Webster Inc · INTRODUCER, CATHETER
2 recalls4 deaths2,839 reports
VIZIGO D138501
Biosense Webster Inc · INTRODUCER, CATHETER
2 recalls2 deaths2,005 reports
Swartz™ 407451
St. Jude Medical, Inc. · INTRODUCER, CATHETER
5 deaths728 reports
Edwards eSheath+ Introducer set 914ESP
Edwards Lifesciences LLC · Introducer, Catheter
22 deaths532 reports
Fast-Cath™ 406849
St. Jude Medical, Inc. · INTRODUCER, CATHETER
420 reports
VIZIGO D138503
Biosense Webster Inc · INTRODUCER, CATHETER
362 reports
Agilis™ G408318
St. Jude Medical, Inc. · INTRODUCER, CATHETER
333 reports
Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-M
St. Jude Medical, Inc. · Introducer, catheter
1 death301 reports

All INTRODUCER, CATHETER devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page