The Food & Drug Administration has issued the most severe type of recall, class I, for the Halo One Thin-walled Guiding Sheath by Bard Peripheral Vascular Inc. The sheath acts as a placement agent and guide for vascular corrective or diagnostic devices that are inserted through an incision in a patient’s leg. The recall states that the tip may separate from the device and that the sheath itself could kink and rip from the actual device when removed from the patient. Potential complications include bleeding, arterial and venous perforation, and even death.
Recalled product information from FDA.gov:
- Product codes HAL545, HAL590, or HAL510F
- Manufactured between April 12, 2016, and July 7, 2016
- Distributed between June 24, 2016, and July 12, 2016