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.
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 mechanical failures (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 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
- 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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