Class 1 Recall for Bard's Halo One Guiding SheathFeb 1, 2017
On January 30, 2017, the U.S. Food and Drug Administration (FDA) announced a Class 1 recall of the Halo One thin-walled guiding sheath. The device is made by C.R. Bard and problems have surfaced associated with sheath separation, kinking, and tip damage during use.
A Class 1 category from the FDA indicates "a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the federal watchdog.
Halo One Sheath Background
The function of the Halo One sheath is to introduce and guide the placement of diagnostic or interventional devices into veins and arteries through an incision in the patient's leg. Bard is withdrawing the device from the market over problems with the sheath body that can separate from the sheath hub during removal of the device from the patient's leg, according to the FDA. Bard also reported that the sheath may kink, and its tip may become damaged during the procedure, which may cause serious adverse health consequences.
These potential malfunctions could result in extended procedure times or additional surgeries that may be needed to remove detached components from the patient. The FDA cautioned that affected products could cause other severe adverse health problems, including internal tears and perforation of veins and arteries, excessive bleeding, and even death.
Halo One Guiding Sheath Recall Details
The recall affects Halo One thin-walled guiding sheaths with product codes HAL545, HAL590, and HAL510F, manufactured between April 12, 2016 and July 7, 2016 and distributed between June 24, 2016 and July 12, 2016. A total of 25 different lot numbers were named in the recall, with 101 devices distributed in Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah, and Washington. C.R. Bard said that customers with affected devices were sent a Medical Device Recall Notification on January 10, and were instructed to remove their unused products, to be returned.
Other Guiding Sheath Recalls
In November 2015, a voluntary Class 1 recall was issued for approximately 7,000 Chariot Guiding Sheaths. It is made by Boston Scientific and had been on the market since June 2015. The guiding sheath is inserted into a patient's blood vessels to help narrower tools slide inside the blood vessel.
Boston Scientific had received 14 reports of "shaft separation," including four reports in which the shaft broke inside a patient's body and had to be surgically removed. The problem was not linked to any sever injuries or death, but life-threatening complications can occur, according to the FDA. Additional surgery may be necessary to retrieve broken pieces. In several cases, shaft separation occurred when doctors were attempting to remove the shaft guide from a patient.
In October 2015, the FDA received a report describing a sheath that "broke in half leaving half still inside the patient as they were pulling it out." Another report that same month said: "While removing the sheath, the sheath broke near the top and remained inside the patient. ...The surgeon then made a small incision and was able to fish out the remaining portion of the Chariot Guiding Sheath."
The FDA warns that the most serious complications occur when broken pieces of the Chariot sheath travel in a patient's bloodstream (embolize) and cause circulation problems or organ damage.
"The most severe outcome of this failure is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment. Obstruction of blood flow can result in injuries such as stroke, kidney damage or damage to the intestines or limbs," according to the report.
Another recall involved the TorFlex Transseptal Guiding Sheath Kit. The manufacturer of this defective medical device, Baylis Medical Company Inc., recalled the device and issued an Urgent Device Recall letter to its customers.
The recalled device was made "for safe and easy catheterization and angiography [a type of X-ray imaging] of specific heart chambers and locations." But, one of the device's components present in the defectively manufactured kits, could cause the removal of small particles. This particulate matter could then "potentially migrate into a patient's bloodstream." Due to the risk of serious health consequences, the device recall was Class 1, according to the FDA.
Legal Advice and Information Regarding Medical Devices
If you or someone you know suffered injuries associated with the use of a guiding sheath, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, please contact Parker Waichman medical device attorneys at 1-800-YOURLAWYER (1-800-968-7529).