December 28, 2015 — The U.S. Food and Drug Administration (FDA) said Boston Scientific has started a Class I recall of its Chariot Guiding Sheath after receiving 14 complaints of the shaft of the device separating. This can cause small pieces to break off the device and enter the patient’s bloodstream.
The FDA said these emboli might obstruct blood flow and require additional interventions to remove device fragments. Obstructed blood flow can result in serious patient injuries such as stroke, kidney damage, damage to the intestines or limbs, or can cause patient death.
On Dec. 15, Boston Scientific sent an urgent medical device recall removal letter to their customers. In the letter they instructed customers to immediately stop using and quarantine any affected products. These products should be returned to the vendor.
Additionally, physicians are encouraged to contact all patients who have undergone procedures involving Chariot to confirm their post-procedure status, as device shaft separation and embolized fragments may not have been recognized at the time of the procedure.
The U.S. recall includes 5,692 units nationwide. The affected device manufacturing dates and between March 17, 2015 to Nov. 10, 2015 and had distribution dates from June 6, 2015 to Nov. 17, 2015
The Chariot Guiding Sheath is used to guide the placement of interventional and diagnostic devices into the veins and arteries of a patient’s arms, hands, legs or feet (peripheral vasculature).
The recall affects all UPNs of the Chariot Guiding Sheaths:
Physicians and health care facilities with questions can contact their Boston Scientific representative or call (800) 811-3211.