On January 30, 2017, Bard Peripheral Vascular Inc. recalled the Halo One Thin-Walled Guiding Sheath because the sheath body may separate from the sheath hub while removing the device from the patient’s leg. The company also reported that the sheath may kink, and that its tip may become damaged during the procedure.
The Halo One Thin-Walled Guiding Sheath is used to introduce and/or guide the placement of interventional and diagnostic devices into veins and arteries through an incision made on a patient’s leg.
The use of affected sheaths may result in prolonged procedure times and an additional surgical intervention to remove detached components from the patient. The affected product may cause other serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.
Affected sheaths have product codes HAL545, HAL590, or HAL510F, and were manufactured between April 12, 2016, and July 7, 2016. Products affected by this recall were distributed between June 24, 2016, and July 12, 2016.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Safety Alert
See also the recall
See also Medical Law Perspectives, October 2015 Report: Unclean, Unsterile, Unsafe: Risks of Injury from Unsterilized Medical Equipment
See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood – The Liability Risks
See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory