Updated POLARx Instructions is Class 1 Recall: FDA

FDA says the Boston Scientific 10/10/24 recall that updated instructions for using its POLARx and POLARx FIT cryoblation balloon catheters is Class 1. An agency statement says the company updated the user instructions for the catheters due to a higher than anticipated number of reports of esophageal injury, specifically atrio-esophageal fistula, after catheter ablation procedures for atrial fibrillation.

“The updates emphasize the risk of atrio-esophageal fistula and practices that may minimize risk,” the statement says, “based on the observation that location, frequency, and intensity of cryoablation applications may be contributing factors to this complication.”

It says using the product may cause serious adverse health consequences, including atrio-esophageal fistula leading to cerebral air embolism, gastrointestinal bleeding, septic shock, and death. FDA says there have been four deaths and seven injuries associated with the recall.