The FDA Deems Halo One Guiding Sheath Recall a Class I
The U.S. Food and Drug Administration (FDA) recently announced a Class 1 recall of C.R. Bard Peripheral Vascular Inc.’s Halo One thin-walled guiding sheaths over issues involving sheath separation, kinking, and tip damage during use. The FDA indicates that a Class I recall is its most serious designation and involves a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
C.R. Bard’s Halo One sheath is meant to enter the vein or artery through an incision in the patient’s leg, guiding the placement of an interventional or diagnostic device. The issue that led to the recall may occur when the sheath body separates from the sheath hub during removal of the device from the patient’s leg. The sheath may also kink and its tip may become damaged during this procedure, which may lead to adverse health consequences.
According to MassDevice, these types of malfunctions may lead to lengthy procedure times or additional surgery to remove detached Halo One components from the patient’s body. The FDA noted that, “The affected product may cause other serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.”
This recall affects Halo One thin-walled guiding sheaths with product codes HAL545, HAL590, and HAL510F that were 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 (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) were involved and 101 devices distributed in Arizona, Florida, Kansas, Louisiana, Maine, Michigan, Missouri, Nevada, New Hampshire, New York, Ohio, Texas, Utah, and Washington.
C.R. Bard indicated that it began notifying those customers in possession of the devices on January 10, instructing them to remove the affected unused products from inventory and return the products to the device maker. According to Diagnostic and Interventional Cardiology, C.R. Bard included a “Recall and Effectiveness Check Form,” which also has an indication for No Product Returned, as well.
The personal injury attorneys at Parker Waichman LLP continue to investigate possible lawsuits involving medical devices. The firm, which has decades of experience representing clients in medical device and drug litigations, continues to offer free legal consultations to individuals with questions about filing a medical device lawsuit.
- R. Bard No Stranger to Medical Device Issues
Bard is not unfamiliar with issues involving its medical devices. For example, Bard retrievable IVC filters have been the subject of controversy over allegedly fracturing and migrating inside patients’ bodies, potentially leading to serious injuries including perforation of the inferior vena cava (IVC) and other organs such as the heart and lungs. When a retrievable IVC filter fractures and migrates, severe pain, bleeding, further embolus, and other life-threatening complications may occur.
The human body has two vena cavas that carry deoxygenated blood to the heart. The inferior vena cava carries blood from the lower body into the heart. The filters are placed in the IVCs of patients diagnosed with deep vein thrombosis (DVT) in their legs to prevent blood clots that break from moving to the heart, lungs, and brain. A filter may be permanent or retrievable. IVC filters designed for removal once the risk of pulmonary embolism subsides are known as retrievable IVC filters. Retrievable filters also appear to be associated with more complications. Warning signs of retrievable IVC filter failure include constant and severe pain in the heart, chest, or other area of the body, as well as shortness of breath. In August 2010, the FDA issued an advisory, after receiving nearly 1,000 adverse event reports involving IVC Filters.
The FDA recently reclassified pelvic mesh devices as high-risk devices that must undergo the agency’s strictest safety evaluation prior to release to the market. In 1976, when medical devices played a much smaller role in medicine, Congress gave the FDA authority over medical devices, allowing the agency a quicker review process for new devices it deemed were substantially equivalent to already approved medical devices. The expedited process is known as a 510(k) review and is the most common review path to market for lower-risk medical devices. Under this route, the FDA only mandates medical device makers demonstrate that a device does what the maker says it does and poses no undue safety risks. Proof of efficacy is not required.
The 510(k) process has been criticized in recent years due to the complexity of the many thousands of devices on the market, rendering the expedited process inadequate in many cases, according to experts. Manufacturers often make changes or modifications to a device after FDA clearance such as incorporating new technology or upgrading device aspects; many changes do not require a 510(k) submission. When the changes could significantly affect the product’s safety or efficacy, or constitute a major change to the intended use of the device, another 510(k) must be submitted.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) created an MDL for all federal lawsuits involving the Bard Recovery, G2, G2X, G2 Express, Eclipse, Meridian, and Denali IVC filters in August 2015. Lawsuits filed into MDL all commonly allege that Bard IVC filters caused injuries when they broke within the blood vessel, including blood vessel perforation, device migration, embolization, and other complications; that the filter was defectively designed; and that Bard was aware of the risks but failed to warn patients or their doctors of these risks. Some lawsuits also allege that complications made filter retrieval difficult.
Filing a Personal Injury Lawsuit
Parker Waichman is a national personal injury law firm that represents clients in drug and medical device lawsuits. If you or someone you know suffered a medical device injury, including involving guide sheaths, IVC filters, and transvaginal mesh and want to learn more about filing a personal injury lawsuit, contact our firm today by calling 1-800-YOURLAWYER (1-800-968-7529).