The Halo One Thin-Walled Guiding Sheath is a medical device used to introduce or guide the placement of diagnostic and interventional devices into the veins and arteries through an incision in the patient’s leg.
Reason for the Halo One Thin-Walled Guiding Sheath Recall
As stated by FDA, this device was recalled because the sheath body may separate from the sheath hub while the device is being removed from the patient’s leg. Also, the sheath may kink or the tip may become damaged during the procedure. FDA reports that use of this device could result in:
- Prolonged procedure time
- Additional surgery to remove detached components from the patient
- Internal tears and perforation to the veins or arteries
- Excessive bleeding
- Death of the patient
This recall has been identified by FDA as a Class I recall, the most serious recall type. FDA has stated that use of this device may cause serious injuries or death. It applies to products manufactured from April 12, 2016, to July 7, 2016, and distributed June 24, 2016, to July 12, 2016.
In the U.S., the recalled devices include 101 units distributed in 14 states – Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah, and Washington.
