Class 1 Recall Issued for Guiding Sheath Medical Device

A Class 1 recall has been issued for Bard’s Halo One Thin-Walled Guiding Sheath. Inserted through an incision in the leg, the Guiding Sheath is used to introduce and/or guide the placement of interventional and diagnostic devices into arteries and veins.

Photo: FDA.gov

A Class 1 recall is the most serious type of recall, meaning use of the device could cause serious injury or death. Reports from Bard Peripheral Vascular Inc. indicate the sheath body and head may separate while removing the device from the leg, causing internal tears and perforation to the veins and arteries. This can also lead to excessive bleeding and death. Additionally, the company reports the sheath could kink and become damaged during the patient’s procedure. 

Healthcare professionals using the Halo One Thin-Walled Guiding Sheath are strongly advised to cease use of the product and discontinue further distribution. Devices with the following product codes and lot numbers are affected by the Class 1 recall:

  • Product Codes: HAL545, HAL590 HAL510F
  • Lot Numbers: 50137556, 50137557, 50137598 50137682 50137723, 50137735, 50137875, 50137965, 50138274, 50138119, 50138118, 50138122, 50138273, 50138435, 50138437, 50138701, 50138439, 50137570, 50137770, 50137979, 50138696, 50137866, 50137924, 50138170, 50138765

The FDA indicates the recalled devices were distributed in multiple states including Florida, Kansas, Maine, Michigan, Arizona, Louisiana, Missouri, New Hampshire, Texas, Utah, Washington, Nevada, New York, and Ohio.

Both consumers and healthcare professionals may report any complications or quality problems to the FDA. Additionally, if you believe you’ve been negatively affected by the use of this medical device or another product, contact the product liability attorneys at The Ruth Law Team for a free case evaluation. Our firm has helped personal injury victims Get Justice for more than 35 years and can be reached 24/7 at 1-888-783-8378.