The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0968-2017·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 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 45 cm (Product Code: HAL545). The recall is being conducted due to complaints of sheath separation, kinking, and/or tip damage during use.

The affected product is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. It is not indicated for use in cerebrovascular or coronary vasculature. The recall covers specific lot numbers 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.

Healthcare providers should stop using the affected lots and contact Bard Peripheral Vascular for instructions on returning the product.

The recalled product

Product
Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheathand introducer sheath. The Halo One Thin-Walled Guiding Sheath is indicated for use inperipheral arterial and venous procedures…
Manufacturer
BARD PERIPHERAL VASCULAR, INC
Category
Medical Device — Vascular Catheter
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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