Boston Scientific Updates Cryoablation Guidelines Following Deaths and Injuries, FDA Issues Serious Recall

The FDA has issued a serious recall for Boston Scientific's cryoablation catheters following reports of four deaths and seven injuries tied to their use in atrial fibrillation treatments[1][2]. This recall is designated as Class I by the FDA, indicating the most serious type of recall due to potential risks of severe injury or death[2]. The recall focuses on updating the instructions for the company's POLARx system to reduce esophageal damage by advising careful monitoring of the balloon's position and avoiding certain high-risk procedures[1]. Measures include monitoring esophageal temperatures and advising against immediate repeated ablations in the same area, helping to prevent potential complications like atrial-esophageal fistula, which can be fatal[1][2].