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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with reported functional defects (separation, kinking, tip damage) that pose a risk of harm during invasive procedures, but no specific injuries or illnesses are reported in the source text.
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 requir
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC
- Affected units
- 101
Distribution
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.
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