The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0969-2017·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 reports 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 90 cm (Product Code: HAL590). 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 units distributed nationwide to New York, Missouri, Florida, Kansas, Michigan, Texas, Nevada, Ohio, Maine, Washington, Louisiana, Arizona, Utah, and New Hampshire. No foreign distribution is reported. Users should stop using the affected devices and contact the manufacturer for instructions.

The recalled product

Product
Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 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 and…
Manufacturer
BARD PERIPHERAL VASCULAR, INC
Category
Medical Device — Vascular Catheters
Hazard
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 →

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