Cook Flexor Sheath Lawsuit Claims Defective Catheter Device Led to Woman’s Death

Complaint alleges prior FDA recalls and years of Flexor Balkin sheath problems should have put Cook on notice to act to protect patients.

The sons of a California woman have filed a wrongful death lawsuit alleging that a defective Cook Flexor Balkin guiding sheath malfunctioned during a vascular procedure, causing fatal injuries.

The complaint (PDF) was brought by Gene Kofman and Oleg Kofman both individually and as co-successors in interest to their mother, Raisa Kofman, in the U.S. District Court for the Northern District of California on December 30. It names Cook Incorporated and Cook Medical LLC as defendants.

Previously, Cook recalled tens of thousands of catheter guiding sheaths in late 2020 due to an increased risk of separation at the bonding site, which could lead to life-threatening injuries. Those recalls were classified by the FDA as Class I, the agency’s most serious designation.

However, the lawsuit claims that despite those recalls, Cook never recalled the Flexor Balkin sheath, even though regulators continued to receive reports of similar failures involving that device. According to the complaint, problems reported to the FDA included material separation, fracture, detachment from the hub and severe bleeding requiring emergency surgical retrieval.

Similar catheter fracture and migration problems have been reported in a growing number of Bard PowerPort lawsuits and AngioDynamics lawsuits, each claiming the use of barium sulfate in the catheter design allows the device to become brittle and prone to failure. As a result, thousands of claims have been filed between two separate litigations against the manufacturers.

According to the Kofmans’ lawsuit, their mother, Raisa Kofman, was being treated at Salinas Valley Health Medical Center on January 31, 2025, when doctors attempted a percutaneous transmural arterial bypass to restore blood flow to her leg. This procedure typically requires only a small incision in the groin, with devices inserted through a guiding sheath placed in the femoral artery.

During the surgery, the lawsuit alleges that a Cook Flexor Balkin catheter sheath separated from its hub as a stent graft was advanced, allowing the device to move deeper into Kofman’s blood vessel. Multiple non-surgical attempts to retrieve the device reportedly failed, forcing surgeons to perform an invasive open cutdown of the femoral artery to remove it.

The complaint claims Kofman suffered massive blood loss, hemorrhagic shock and required blood transfusions and ventilator support following the emergency intervention. Although the procedure was completed, she was transferred to intensive care in critical condition.

In the weeks that followed, Kofman allegedly experienced ongoing complications, including severe bleeding and a large groin hematoma. She was re-hospitalized in March 2025, and later suffered respiratory and cardiac arrest after aspirating. She died on March 25, 2025, according to the lawsuit.

The Kofmans allege that Cook has long been aware that its Flexor guiding sheaths are prone to separation, detachment and breakage inside patients’ blood vessels. However, the company has continued to market the device despite their defective design, inadequate warnings and repeated reports of failures, which should have triggered a recall.

The lawsuit also claims the sheath poses an unreasonable risk during normal, foreseeable procedures, noting that federal regulators have received more than 1,700 adverse event reports involving Cook Flexor introducers and sheaths since at least 2015.

“At all times relevant to this action, the officers and/or directors of the Defendants participated in, authorized and/or directed the production and promotion of their Balkin sheaths when they knew or should have known of the sheaths’ hazardous and dangerous propensities, and thereby actively participated in the tortious conduct that resulted in the injuries suffered by the Decedent and the Plaintiffs.”

— Gene Kofman et al v. Cook Incorporated et al

The Kofmans’ lawsuit raises claims of strict product liability, negligence, failure to warn, failure to recall and wrongful death. It seeks compensatory and punitive damages, alleging the defendants acted with reckless disregard for patient safety and that the sheath’s failure was a substantial factor in causing Raisa Kofman’s death.

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