Agency classClass IOur severity:Severe FDA (Devices)·Z-0970-2017·Announced 2017-01-25

Bard Halo One Introducer Sheath Recalled for Separation and Kinking

Bard Peripheral Vascular is recalling Halo One 5F Introducer Sheaths due to complaints of sheath separation, kinking, and tip damage during use.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Complaints of sheath separation, kinking, and/or tip damage during use."

Plain-English summary

Bard Peripheral Vascular, Inc. is recalling 101 units of the Halo One 5F Introducer Sheath 10 cm 5 pack (Product Code: HAL510F). The recall is due to complaints of sheath separation, kinking, and/or tip damage during use.

The affected product is a thin-walled guiding sheath indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. It is not indicated for use in the neurovasculature or coronary vasculature. The recall covers specific lot numbers 50137866, 50137924, 50138170, and 50138765.

The product was distributed nationwide to facilities in New York, Missouri, Florida, Kansas, Michigan, Texas, Nevada, Ohio, Maine, Washington, Louisiana, Arizona, Utah, and New Hampshire. There was no foreign distribution. Users should stop using the affected devices and contact the manufacturer for instructions on return or replacement.

The recalled product

Product: Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial…
Manufacturer: BARD PERIPHERAL VASCULAR, INC
Category: Medical Device — Vascular Catheter
Hazard: device-failure
mechanical-defect
Affected units: 101

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 3 recalled by BARD PERIPHERAL VASCULAR, INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · BARD PERIPHERAL VASCULAR, INC

See all →

High
Bard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
High
Catheter cutdown trays recalled over damage to the outer tray
FDA (Devices) · 2026-02-25
High
Drainage catheter trays recalled over safety indicators showing the wrong position
FDA (Devices) · 2025-12-17
Moderate
Vein ablation generators recalled over software falsely flagging working catheters
FDA (Devices) · 2025-10-08
Critical
Rotarex Atherectomy Catheter Recalled for Helix Fracture Risk
FDA (Devices) · 2025-03-12

Same hazard · device failure