Boston Sci对POLARx冷冻消融导管进行安全召回

Boston Scientific (NYSE:BSX) has issued a correction recall for its POLARx and POLARx FIT cryoablation balloon catheters over concerns that they may cause serious esophageal injuries or even death.

The company has issued updated instructions for the devices due to a higher-than-expected number of reports of esophageal injury, including atrio-esophageal fistula, following catheter ablation procedures for atrial fibrillation. The new instructions are intended to help minimize the risk of potential injury, according to the FDA.

The FDA has classified the recall as the most serious type as use of the device could cause serious injury or death if the updated instructions are not followed. The agency also classified the recall as a correction, rather than a product removal.

So far, four deaths and seven injuries have been reported, the agency said.

The company (NYSE:BSX) sent an Urgent Medical Device Advisory to customers advising them of the updated instructions on Oct. 10, the agency added.

The Boston Scientific Cardiac Cryoablation System using POLARx Cryoablation Balloon Catheters is indicated for the treatment of recurrent, symptomatic atrial fibrillation, which leads to irregular, fast heartbeats that resolve within seven days that do not respond to medication, according to the FDA.