The affected devices are used in catheter-based ablation procedures for treating atrial fibrillation. Boston Scientific confirmed that while the devices are not being removed from the market, clinicians are being urged to follow updated guidelines to minimize risk of esophageal injury, according to an Dec. 18 news release from the FDA.
The key changes to the device’s use instructions include more stringent recommendations for cryoblation procedures, specifically to monitor the cryoblation’s position relative to the esophagus and avoid cryoablation directly over the esophagus or posterior left atrium.
The FDA classified this recall as the most serious type, citing the risk of injury or death if the updated instructions are not followed.
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