Boston Scientific Corp.’s Maple Grove campus is recalling its global supply of 7,000 Chariot Guiding Sheaths because parts of the device can break off during medical procedures and obstruct blood flow.
The company says doctors who used the Chariot sheath for minimally invasive procedures in the legs and arms should check back with those patients to make sure they’re doing OK.
The device is relatively new to the market. The U.S. Food and Drug Administration gave Boston Scientific clearance to sell the Chariot Guiding Sheath on June 5, according to FDA records. It was supposed to be substantially equivalent to an earlier model, the Terumo Pinnacle Destination sheath, approved in 2009.
On Nov. 19, the company informed doctors and hospitals that they should immediately stop using Chariot sheaths. Although the FDA recall notice was not yet published Wednesday, Boston Scientific said in a news release that regulators have classified the company’s voluntary action as a Class 1 recall, meaning use of the device can lead to serious health consequences or death.
The Chariot is considered a “guiding sheath” because it is inserted in a patient’s blood vessels so that other, thinner tools can slide through it and be easily directed to disease sites. But as of Nov. 19, the company had received 14 reports of “shaft separation,” including four cases where the separation happened on the end inserted into the patient’s body.
On Oct. 12, for example, the company told the FDA about an incident that happened after a Chariot sheath was used to place a stent in a patient’s leg artery:
“At the end of the procedure, as the physician was coming out, the chariot sheath broke in half leaving half still inside the patient as they were pulling it out. They went ahead and kept pulling the inner wiring of the sheath. When the rest of the device became visible, they grabbed a hemostat to pull the remaining portion of the sheath out of the patient. No patient complications were reported and the patient’s status is fine,” the report on file with the FDA says.
None of the incidents led to death or permanent injuries, the company said, though the company noted that one serious outcome could be additional medical interventions to remove fragments left inside the body.
The company is encouraging doctors to contact their past Chariot patients to check on their well-being, since it may not have been evident at the time that fragments broke off during the procedure.