PlainRecalls
FDA Devices Critical Class I Terminated

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 venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.

Reported: January 25, 2017 Initiated: December 2, 2016 #Z-0969-2017

Product Description

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 venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.

Reason for Recall

Complaints of sheath separation, kinking, and/or tip damage during use.

Details

Units Affected
101
Distribution
Nationwide Distribution to NY, MO, NY, NY, FL, KS, MI, TX, NV, OH, ME, WA, LA, AZ, UT, NH. No foreign distribution.
Location
Tempe, AZ

Frequently Asked Questions

What product was recalled? ▼
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 venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.. Recalled by BARD PERIPHERAL VASCULAR, INC. Units affected: 101.
Why was this product recalled? ▼
Complaints of sheath separation, kinking, and/or tip damage during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 25, 2017. Severity: Critical. Recall number: Z-0969-2017.

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