Bard Catheter Warning Issued by FDA Regarding Risk of Tip Separation, Other Complications Linked to at Least 4 Deaths

Federal safety officials are warning consumers of a defect in some Bard catheters used primarily for the removal of blood clots, indicating that the rotating tip of these devices may be prone to fracturing or breaking off under certain conditions.

The Bard Peripheral Vascular Rotarex Atherectomy Systems are catheters designed to fragment and remove blood clots from arteries with stents, grafts or bypasses. These systems consist of a body that connects to a collection bag and a rotating helix tip, which navigates through arteries to break up clots.

According to a U.S. Food and Drug Administration (FDA) early warning letter issued on February 6, certain Bard Rotarex Atherectomy System catheters are prone to tip fractures or breaking during procedures involving stress, wear, high temperatures, friction or localized pressure, which could lead to severe injuries or death.

The recall announcement comes as Bard currently faces over 1,000 PowerPort catheter lawsuits that also contain an alleged design defect. The Bard PowerPort lawsuits claim that the barium sulfate used in these devices can degrade, leading to fissures and cracks. Over time, these defects may cause the catheters to fracture and migrate throughout the body.

According to the FDA, the Bard Rotarex Atherectomy System issues have already led to 115 reported cases requiring interventions after the helix tip fractured or broke, in addition to 30 serious injuries and four deaths.

Bard Peripheral Vascular issued a letter to affected customers on February 5, for the following devices distributed in the U.S.:

• SET Rotarex Description: 6 F x 110 cm, UDI-DI: (01)07640142811855, Catalog Number: 80236
• SET Rotarex Description: 6 F x 135 cm, UDI-DI: (01)07640142811862, Catalog Number: 80237
• SET Rotarex Description: 8 F x 85 cm, UDI-DI: (01)07640142811879, Catalog Number: 80238
• SET Rotarex Description: 8 F x 110 cm, UDI-DI: (01)07640142811886, Catalog Number: 80239

The letter urges customers to review updated use instructions and follow new online training procedures. In addition, customers are encouraged to use kink resistant sheaths for the device, maintain adequate blood flow through the catheter, maintain constant catheter movement during procedures, and closely monitor the catheter for any resistance.

U.S. customers with adverse reactions, quality problems or additional questions should contact the Bard parent company, Becton, Dickinson and Company, North American Regional Complaint Center at productcomplaints@bd.com or call 1-844-823-5433, and when prompted say “product complaints.”

Health care professionals, patients and their families can also report adverse reactions or quality problems with these devices to the FDA’s safety information and adverse event reporting program, MedWatch.

Bard PowerPort Catheter Lawsuits

Given the common questions of fact and law raised in the Bard port catheter lawsuits filed throughout the federal court system, a Bard PowerPort MDL (multidistrict litigation) was established before U.S. District Judge David G. Campbell in the District of Arizona in August 2023.

Since the litigation was centralized, the parties have been working through pretrial proceedings and preparing a group of representative claims for early trial dates to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.

After initially selecting 24 potential bellwether cases in December 2023, Bard PowerPort lawyers narrowed that list to 15 claims late last year. These claims are now going through the next phase of discovery. The Court previously indicated that all discovery must be completed by January 31, 2025, with a final group of six potential trial picks selected by early March 2025. However, Judge Campbell recently agreed to extend deadlines, giving the parties until mid-April 2025 to finalize their selections.

While the outcomes of these early bellwether trials will not have any binding impact on other claims pending in the MDL or state courts, they are expected to have a major impact on future Bard PowerPort lawsuit settlement negotiations, which will be necessary to avoid hundreds of individual claims being set for trial in the coming years.