The U.S. Food and Drug Administration (FDA) has issued a recall of the Bard Halo One Thin-Walled Guiding Sheath, a device used to place interventional and diagnostic devices into patients’ arteries and veins via an incision in the leg. The recall has been listed as Class I, which is the most serious recall class possible. Class I recalls are issued only when the use of the recalled device may cause serious injuries, including death.
Bard Peripheral Vascular, Inc., the manufacturer of the Halo One, issued a recall notice on January 10, telling its customers to cease use and distribution of the recalled products. The FDA followed up with a January 30 safety alert, listing the recall as Class I.
The FDA statement read, in part, “The affected product may cause other serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.” The recall further states that using the Halo One could mean longer procedure times for the patient and additional surgeries to retrieve detached parts.
The problem with the Halo One Thin-Walled Guiding Sheath is that the sheath itself may detach from the device during removal from the patient’s leg. Bard also said that the sheath can kink and that the tip of the sheath can be damaged during use, thus causing the aforementioned tears and perforations.
The recall covers 101 Halo One Thin-Walled Guiding Sheaths made between April 12, 2016 and July 7, 2016. The devices were distributed from June 24, 2016 to July 12, 2016 to facilities in Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah and Washington.
Recalled product codes and lot numbers follow:
- 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
Patients and healthcare providers are urged to report any adverse reactions to the FDA via:
- MedWatch: The FDA Safety Information and Adverse Event Reporting Program
- FAX 800-FDA-0178, or
- Phone 800-FDA-1088.